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FDA_NCIt_Subsets 2008-06-27.xls

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									Source Subset   Subset Name                                 Concept   Source PT                                            Source Definition                               Source Synonym(s)
       Code                                                 Code
FDA    C54583   Adverse Event Outcome ICSR Terminology      C49489    Adverse Event Outcome                                                                                Outcome Attributed to Adverse Event
FDA    C54583   Adverse Event Outcome ICSR Terminology      C2849     Congenital Defect/Deformity                                                                          Deformity/defect, congenital|Defect/deformity, congenital
FDA    C54583   Adverse Event Outcome ICSR Terminology      C28554    Death
FDA    C54583   Adverse Event Outcome ICSR Terminology      C21007    Disability
FDA    C54583   Adverse Event Outcome ICSR Terminology      C25179    Hospitalization
FDA    C54583   Adverse Event Outcome ICSR Terminology      C52668    Intervention Required
FDA    C54583   Adverse Event Outcome ICSR Terminology      C50913    Invalid Data
FDA    C54583   Adverse Event Outcome ICSR Terminology      C41337    Life Threatening                                                                                     Life Threatening Adverse Event
FDA    C54583   Adverse Event Outcome ICSR Terminology      C60812    Multiple Deaths And Serious Injuries
FDA    C54583   Adverse Event Outcome ICSR Terminology      C53269    No Information Available                                                                             No Answer Provided
FDA    C54583   Adverse Event Outcome ICSR Terminology      C48660    Not Applicable
FDA    C54583   Adverse Event Outcome ICSR Terminology      C17649    Other                                                                                                Other
FDA    C54583   Adverse Event Outcome ICSR Terminology      C60811    Pediatric Death
FDA    C54583   Adverse Event Outcome ICSR Terminology      C17998    Unknown                                                                                              Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known)
FDA    C54595   Device Usage ICSR Terminology               C53612    Initial
FDA    C54595   Device Usage ICSR Terminology               C53613    Reuse
FDA    C54595   Device Usage ICSR Terminology               C17998    Unknown                                                                                              Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known)
FDA    C54595   Device Usage ICSR Terminology               C38046    Unspecified
FDA    C54595   Device Usage ICSR Terminology               C53645    Usage of Device
FDA    C54447   Individual Case Safety Report Terminology   C53586    Additional Information
FDA    C54447   Individual Case Safety Report Terminology   C41331    Adverse Event
FDA    C54447   Individual Case Safety Report Terminology   C49489    Adverse Event Outcome                                                                                Outcome Attributed to Adverse Event
FDA    C54447   Individual Case Safety Report Terminology   C25150    Age
FDA    C54447   Individual Case Safety Report Terminology   C16281    Ambulatory Care Facility
FDA    C54447   Individual Case Safety Report Terminology   C51957    Ambulatory Surgical Center
FDA    C54447   Individual Case Safety Report Terminology   C51945    Ambulatory Surgical Facility                                                                         Outpatient Clinic/Surgery
FDA    C54447   Individual Case Safety Report Terminology   C53451    Approximate Age of Device
FDA    C54447   Individual Case Safety Report Terminology   C51959    Attorney
FDA    C54447   Individual Case Safety Report Terminology   C51804    Audiologist
FDA    C54447   Individual Case Safety Report Terminology   C51960    Biomedical Engineer
FDA    C54447   Individual Case Safety Report Terminology   C51963    Blood Bank
FDA    C54447   Individual Case Safety Report Terminology   C51964    Bloodmobile
FDA    C54447   Individual Case Safety Report Terminology   C53510    Cardiac Catheterization Suite                                                                        Catheterization Suite
FDA    C54447   Individual Case Safety Report Terminology   C51967    Chemotherapy Center
FDA    C54447   Individual Case Safety Report Terminology   C51282    Clinic - Walk in, Other
FDA    C54447   Individual Case Safety Report Terminology   C15206    Clinical Study
FDA    C54447   Individual Case Safety Report Terminology   C51968    Company Representative
FDA    C54447   Individual Case Safety Report Terminology   C2849     Congenital Defect/Deformity                                                                          Deformity/defect, congenital|Defect/deformity, congenital
FDA    C54447   Individual Case Safety Report Terminology   C53568    Consumer
FDA    C54447   Individual Case Safety Report Terminology   C53585    Correction
FDA    C54447   Individual Case Safety Report Terminology   C53619    Corrective Action Number
FDA    C54447   Individual Case Safety Report Terminology   C25464    Country
FDA    C54447   Individual Case Safety Report Terminology   C53486    Date of Concomitant Therapy
FDA    C54447   Individual Case Safety Report Terminology   C53481    Date of Device Return to Manufacturer
FDA    C54447   Individual Case Safety Report Terminology   C28554    Death
FDA    C54447   Individual Case Safety Report Terminology   C53428    Dental Assistant
FDA    C54447   Individual Case Safety Report Terminology   C53293    Dental Hygienist
FDA    C54447   Individual Case Safety Report Terminology   C52654    Dentist
FDA    C54447   Individual Case Safety Report Terminology   C53449    Device Available for Evaluation
FDA    C54447   Individual Case Safety Report Terminology   C53588    Device Evaluation
FDA    C54447   Individual Case Safety Report Terminology   C53601    Device Evaluation Anticipated But Not Yet Begun
FDA    C54447   Individual Case Safety Report Terminology   C53602    Device Labeled for Single Use
FDA    C54447   Individual Case Safety Report Terminology   C53599    Device Not Made by Company
FDA    C54447   Individual Case Safety Report Terminology   C54026    Device Problem
FDA    C54447   Individual Case Safety Report Terminology   C53600    Device Problem Already Known No Evaluation Necessary
FDA    C54447   Individual Case Safety Report Terminology   C53598    Device Received in Condition Which Made Analysis Impossible
FDA    C54447   Individual Case Safety Report Terminology   C53591    Device Returned to Manufacturer for Evaluation
FDA    C54447   Individual Case Safety Report Terminology   C53274    Device Unattended
FDA    C54447   Individual Case Safety Report Terminology   C53518    Dialysis Center
FDA    C54447   Individual Case Safety Report Terminology   C53512    Dialysis Unit
FDA    C54447   Individual Case Safety Report Terminology   C28248    Dietician
FDA    C54447   Individual Case Safety Report Terminology   C21007    Disability
FDA    C54447   Individual Case Safety Report Terminology   C48289    Distributor
FDA    C54447   Individual Case Safety Report Terminology   C53519    Drug Clinic
FDA    C54447   Individual Case Safety Report Terminology   C53417    Emergency Medical Technician
FDA    C54447   Individual Case Safety Report Terminology   C53513    Emergency Room
FDA    C54447   Individual Case Safety Report Terminology   C53592    Evaluation Summary Status
FDA    C54447   Individual Case Safety Report Terminology   C53514    Examination Room
FDA    C54447   Individual Case Safety Report Terminology   C25745    Failure
FDA    C54447   Individual Case Safety Report Terminology   C53580    FDA Requested
FDA    C54447   Individual Case Safety Report Terminology   C16576    Female
FDA    C54447   Individual Case Safety Report Terminology   C53576    Fifteen-Day
FDA    C54447   Individual Case Safety Report Terminology   C53573    Five-Day
FDA    C54447   Individual Case Safety Report Terminology   C53579    Follow-Up
FDA    C54447   Individual Case Safety Report Terminology   C25512    Foreign
FDA    C54447   Individual Case Safety Report Terminology   C51966    Free-Standing Cardiac Catheterization Laboratory
FDA    C54447   Individual Case Safety Report Terminology   C53287    Health Care Professional
FDA    C54447   Individual Case Safety Report Terminology   C18002    Home
FDA    C54447   Individual Case Safety Report Terminology   C53429    Home Health Aid
FDA    C54447   Individual Case Safety Report Terminology   C53532    Hospice
FDA    C54447   Individual Case Safety Report Terminology   C16696    Hospital
FDA    C54447   Individual Case Safety Report Terminology   C53433    Hospital Service Technician
FDA    C54447   Individual Case Safety Report Terminology   C25179    Hospitalization
FDA    C54447   Individual Case Safety Report Terminology   C50414    Hospitalization Required                                                                             Required hospitalization
FDA    C54447   Individual Case Safety Report Terminology   C53521    Imaging Center - Mobile
FDA    C54447   Individual Case Safety Report Terminology   C53617    Importer                                          Any person who imports a device into the
                                                                                                                        United States and who furthers the
                                                                                                                        marketing of a device from the original place
                                                                                                                        of manufacture to the person who makes
                                                                                                                        final delivery or sale to the ultimate user, but
                                                                                                                        who does not repackage or otherwise
                                                                                                                        change the container, wrapper, or labeling of
                                                                                                                        the device or device package. If you
                                                                                                                        repackage or otherwise change the
                                                                                                                        container, wrapper, or labeling, you are
                                                                                                                        considered a manufacturer as defined in this
                                                                                                                        section.

FDA    C54447   Individual Case Safety Report Terminology   C53538    In Transit to User/Medical Facility
FDA    C54447   Individual Case Safety Report Terminology   C53620    Initial
FDA    C54447   Individual Case Safety Report Terminology   C53612    Initial
FDA    C54447   Individual Case Safety Report Terminology   C53604    Inspection
FDA    C54447   Individual Case Safety Report Terminology   C53511    Intensive Care Unit                                                                                  Critical Care Unit
FDA    C54447   Individual Case Safety Report Terminology   C52668    Intervention Required
FDA    C54447   Individual Case Safety Report Terminology   C50913    Invalid Data
FDA    C54447   Individual Case Safety Report Terminology   C37984    Laboratory
FDA    C54447   Individual Case Safety Report Terminology   C53551    Laboratory or Pathology Department
FDA    C54447   Individual Case Safety Report Terminology   C41337    Life Threatening                                                                                     Life Threatening Adverse Event
FDA    C54447   Individual Case Safety Report Terminology   C48471    Literature
FDA    C54447   Individual Case Safety Report Terminology   C53509    Location Where Event Occurred
FDA    C54447   Individual Case Safety Report Terminology   C53530    Long-Term Care Facility
FDA    C54447   Individual Case Safety Report Terminology   C20197    Male
FDA    C54447   Individual Case Safety Report Terminology   C53581    Manufacturer Response to Voluntary Report
FDA    C54447   Individual Case Safety Report Terminology   C53515    Maternity Ward - Nursery
FDA    C54447   Individual Case Safety Report Terminology   C53430    Medical Assistant
FDA    C54447   Individual Case Safety Report Terminology   C53442    Medical Equipment Company Technician or Representative
FDA    C54447   Individual Case Safety Report Terminology   C54027    Medical Problem                                                                                      Patient Problem Code|Patient Problem
FDA    C54447   Individual Case Safety Report Terminology   C53418    Medical Technologist
FDA    C54447   Individual Case Safety Report Terminology   C53523    Mobile Health Unit
FDA    C54447   Individual Case Safety Report Terminology   C53606    Modification or Adjustment
FDA    C54447   Individual Case Safety Report Terminology   C53524    MRI Center                                                                                           MRI Centers
FDA    C54447   Individual Case Safety Report Terminology   C60812    Multiple Deaths And Serious Injuries
FDA    C54447   Individual Case Safety Report Terminology   C49487    No
FDA    C54447   Individual Case Safety Report Terminology   C53269    No Information Available                                                                             No Answer Provided
FDA    C54447   Individual Case Safety Report Terminology   C48660    Not Applicable
FDA    C54447   Individual Case Safety Report Terminology   C25297    Notification
FDA   C54447   Individual Case Safety Report Terminology                   C53419   Nuclear Medicine Technologist
FDA   C54447   Individual Case Safety Report Terminology                   C20821   Nurse
FDA   C54447   Individual Case Safety Report Terminology                   C53431   Nursing Assistant
FDA   C54447   Individual Case Safety Report Terminology                   C53533   Nursing Home
FDA   C54447   Individual Case Safety Report Terminology                   C25193   Occupation
FDA   C54447   Individual Case Safety Report Terminology                   C28174   Occupational Therapist
FDA   C54447   Individual Case Safety Report Terminology                   C53516   Operating Room
FDA   C54447   Individual Case Safety Report Terminology                   C53272   Operator of Medical Device
FDA   C54447   Individual Case Safety Report Terminology                   C53618   Original Equipment Manufacturer                                                              OEM
FDA   C54447   Individual Case Safety Report Terminology                   C17649   Other                                                                                        Other
FDA   C54447   Individual Case Safety Report Terminology                   C53427   Other Caregiver
FDA   C54447   Individual Case Safety Report Terminology                   C53289   Other Health Care Professional
FDA   C54447   Individual Case Safety Report Terminology                   C53263   Other Personal Medical History
FDA   C54447   Individual Case Safety Report Terminology                   C53541   Outdoors
FDA   C54447   Individual Case Safety Report Terminology                   C53548   Outpatient Diagnostic Facility
FDA   C54447   Individual Case Safety Report Terminology                   C53549   Outpatient Treatment Facility
FDA   C54447   Individual Case Safety Report Terminology                   C53420   Paramedic
FDA   C54447   Individual Case Safety Report Terminology                   C53542   Park
FDA   C54447   Individual Case Safety Report Terminology                   C16960   Patient                                                                                      Lay User/Patient
FDA   C54447   Individual Case Safety Report Terminology                   C53432   Patient Family Member Or Friend
FDA   C54447   Individual Case Safety Report Terminology                   C53607   Patient Monitoring
FDA   C54447   Individual Case Safety Report Terminology                   C60811   Pediatric Death
FDA   C54447   Individual Case Safety Report Terminology                   C53578   Periodic
FDA   C54447   Individual Case Safety Report Terminology                   C51840   Pharmacist
FDA   C54447   Individual Case Safety Report Terminology                   C53421   Phlebotomist
FDA   C54447   Individual Case Safety Report Terminology                   C53422   Physical Therapist
FDA   C54447   Individual Case Safety Report Terminology                   C25741   Physician
FDA   C54447   Individual Case Safety Report Terminology                   C53423   Physician Assistant
FDA   C54447   Individual Case Safety Report Terminology                   C53446   Physicist
FDA   C54447   Individual Case Safety Report Terminology                   C53689   Playground
FDA   C54447   Individual Case Safety Report Terminology                   C53054   Product Problem
FDA   C54447   Individual Case Safety Report Terminology                   C53564   Psychiatric Center-Walk in, Other
FDA   C54447   Individual Case Safety Report Terminology                   C53536   Psychiatric Facility
FDA   C54447   Individual Case Safety Report Terminology                   C53546   Public Building
FDA   C54447   Individual Case Safety Report Terminology                   C53688   Public Venue
FDA   C54447   Individual Case Safety Report Terminology                   C17049   Race
FDA   C54447   Individual Case Safety Report Terminology                   C53424   Radiologic Technologist
FDA   C54447   Individual Case Safety Report Terminology                   C53517   Radiology Department
FDA   C54447   Individual Case Safety Report Terminology                   C53593   Reason for Non-Evaluation
FDA   C54447   Individual Case Safety Report Terminology                   C53609   Recall                                      Recalls are regulatory actions that enable
                                                                                                                                FDA to remove a hazardous, potentially
                                                                                                                                hazardous, or a misbranded product from
                                                                                                                                the marketplace. Recalls are also used to
                                                                                                                                convey additional information to the user
                                                                                                                                concerning the safe use of the product.
                                                                                                                                Either FDA or the manufacturer can initiate
                                                                                                                                recalls.
FDA   C54447   Individual Case Safety Report Terminology                   C53535   Rehabilitation Center
FDA   C54447   Individual Case Safety Report Terminology                   C53608   Relabeling
FDA   C54447   Individual Case Safety Report Terminology                   C53611   Repair
FDA   C54447   Individual Case Safety Report Terminology                   C53610   Replacement
FDA   C54447   Individual Case Safety Report Terminology                   C53566   Report Source
FDA   C54447   Individual Case Safety Report Terminology                   C53614   Reprocessor
FDA   C54447   Individual Case Safety Report Terminology                   C53425   Respiratory Therapist
FDA   C54447   Individual Case Safety Report Terminology                   C53587   Response to FDA Request
FDA   C54447   Individual Case Safety Report Terminology                   C53537   Retirement Home
FDA   C54447   Individual Case Safety Report Terminology                   C53613   Reuse
FDA   C54447   Individual Case Safety Report Terminology                   C53448   Risk Manager
FDA   C54447   Individual Case Safety Report Terminology                   C17118   School
FDA   C54447   Individual Case Safety Report Terminology                   C53569   Serious Injury
FDA   C54447   Individual Case Safety Report Terminology                   C53441   Service and Testing Personnel
FDA   C54447   Individual Case Safety Report Terminology                   C53273   Service Personnel
FDA   C54447   Individual Case Safety Report Terminology                   C53574   Seven-Day
FDA   C54447   Individual Case Safety Report Terminology                   C28421   Sex
FDA   C54447   Individual Case Safety Report Terminology                   C53563   Single Use and Reused
FDA   C54447   Individual Case Safety Report Terminology                   C28247   Speech Therapist
FDA   C54447   Individual Case Safety Report Terminology                   C53687   Stationary Imaging Center
FDA   C54447   Individual Case Safety Report Terminology                   C25690   Street
FDA   C54447   Individual Case Safety Report Terminology                   C53575   Ten-Day
FDA   C54447   Individual Case Safety Report Terminology                   C36292   Test Result
FDA   C54447   Individual Case Safety Report Terminology                   C53577   Thirty-Day
FDA   C54447   Individual Case Safety Report Terminology                   C53525   Tuberculosis Clinic
FDA   C54447   Individual Case Safety Report Terminology                   C53265   Type of Device
FDA   C54447   Individual Case Safety Report Terminology                   C53053   Type of Event                                                                                Type of Reportable Event
FDA   C54447   Individual Case Safety Report Terminology                   C53584   Type of Follow-Up
FDA   C54447   Individual Case Safety Report Terminology                   C54597   Type Of Manufacturer
FDA   C54447   Individual Case Safety Report Terminology                   C53603   Type of Remedial Action
FDA   C54447   Individual Case Safety Report Terminology                   C53571   Type of Report                                                                               Report Type
FDA   C54447   Individual Case Safety Report Terminology                   C53615   Type of Reporter                                                                             Reporter Type
FDA   C54447   Individual Case Safety Report Terminology                   C17998   Unknown                                                                                      Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known)
FDA   C54447   Individual Case Safety Report Terminology                   C38046   Unspecified
FDA   C54447   Individual Case Safety Report Terminology                   C53528   Urgent Care Center
FDA   C54447   Individual Case Safety Report Terminology                   C53645   Usage of Device
FDA   C54447   Individual Case Safety Report Terminology                   C53567   User Facility                               Device user facility means a hospital,
                                                                                                                                ambulatory surgical facility, nursing home,
                                                                                                                                outpatient diagnostic facility, or outpatient
                                                                                                                                treatment facility as defined in this section,
                                                                                                                                which is not a physician's office, as defined
                                                                                                                                in this section. School nurse offices and
                                                                                                                                employee health units are not device user
                                                                                                                                facilities.
FDA   C54447   Individual Case Safety Report Terminology                   C53552   Ward or Patient Room
FDA   C54447   Individual Case Safety Report Terminology                   C25208   Weight
FDA   C54447   Individual Case Safety Report Terminology                   C49488   Yes
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C41332   Adverse Reaction
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C16352   African American
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C41259   American Indian or Alaska Native
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C41260   Asian
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C60654   Conditional Approval
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C50646   Contraindication                            Any special symptom or circumstance that
                                                                                                                                renders the use of a remedy or the carrying
                                                                                                                                out of a procedure inadvisable, usually
                                                                                                                                because of the risk.
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C54346   Dose Modification
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C60655   Duration Of Use
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C16576   Female
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C54708   Interaction
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C54344   Limitation Of Use
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C54352   Limited Or No Information
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C20197   Male
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C41219   Native Hawaiian or Other Pacific Islander
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C17049   Race
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C54350   Second Line Treatment
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C28421   Sex
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C54351   Use With Caution
FDA   C54599   Limitation Of Use Structured Product Labeling Terminology   C41261   White
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C16281   Ambulatory Care Facility
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C51957   Ambulatory Surgical Center
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C51945   Ambulatory Surgical Facility                                                                 Outpatient Clinic/Surgery
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C51963   Blood Bank
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C51964   Bloodmobile
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C53510   Cardiac Catheterization Suite                                                                Catheterization Suite
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C51967   Chemotherapy Center
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C51282   Clinic - Walk in, Other
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C53518   Dialysis Center
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C53512   Dialysis Unit
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C53519   Drug Clinic
FDA   C54590   Location Of Event Occurrence ICSR Terminology               C53513   Emergency Room
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53514   Examination Room
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C51966   Free-Standing Cardiac Catheterization Laboratory
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C18002   Home
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53532   Hospice
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C16696   Hospital
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53521   Imaging Center - Mobile
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53538   In Transit to User/Medical Facility
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53511   Intensive Care Unit                                              Critical Care Unit
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C50913   Invalid Data
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C37984   Laboratory
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53551   Laboratory or Pathology Department
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53509   Location Where Event Occurred
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53530   Long-Term Care Facility
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53515   Maternity Ward - Nursery
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53523   Mobile Health Unit
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53524   MRI Center                                                       MRI Centers
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53269   No Information Available                                         No Answer Provided
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C48660   Not Applicable
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53533   Nursing Home
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53516   Operating Room
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C17649   Other                                                            Other
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53541   Outdoors
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53548   Outpatient Diagnostic Facility
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53549   Outpatient Treatment Facility
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53542   Park
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53689   Playground
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53564   Psychiatric Center-Walk in, Other
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53536   Psychiatric Facility
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53546   Public Building
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53688   Public Venue
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53517   Radiology Department
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53535   Rehabilitation Center
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53537   Retirement Home
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C17118   School
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53687   Stationary Imaging Center
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C25690   Street
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53525   Tuberculosis Clinic
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C17998   Unknown                                                          Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known)
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53528   Urgent Care Center
FDA   C54590   Location Of Event Occurrence ICSR Terminology                C53552   Ward or Patient Room
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50372   Absorber
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49804   Absorber (CO2)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49806   Accumulator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49807   Actuator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49808   Adapter (Adaptor)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49810   Air cleaner
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50339   Air Eliminator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49811   Air pump assembly
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49813   Alarm
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49812   Alarm, assembly
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49814   Alarm, audible
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49817   Alarm, high inspiratory pressure
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49815   Alarm, LED
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49819   Alarm, low inspiratory pressure
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49818   Alarm, oxygen pressure
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49820   Alarm, power
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49816   Alarm, pressure
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49821   Alarm, self
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49822   Alarm, visual
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49823   Alarm, volume
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49824   Alternator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50057   Altimeter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49825   Amplifier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49826   Analyzer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49827   Annunciator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49828   Antenna
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50341   Applicator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49829   Arrester
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49830   Attenuator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50317   Automatic Injection System
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49831   Backpanel
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49832   Backplane
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49958   Bacterial filter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49833   Baffle
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49834   Bags
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49835   Ball
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49836   Ballast
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49837   Balloon
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49838   Barrier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49839   Battery
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50346   Battery Charger
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49841   Beam splitter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49842   Bearings
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C51066   Bed, Assist Bar
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49843   Bell
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49844   Belt
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49845   Blower
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49846   Bobbin
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50056   Bolometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49847   Bolt
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50289   Bolus mechanism
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49848   Bottom dead center sensor bracket
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49849   Brake
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49850   Breathing circuit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49851   Brush
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50354   Bubble Detector
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49852   Bus
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49853   Bushing
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49854   Buzzer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49855   Cable
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49857   Calibrator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49858   Camera
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50343   Cannula
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50274   Cannula Guide
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49859   Cannula, inner
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49860   Cannula, outer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49861   Cap
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49862   Capacitor (ceramic chip)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49863   Carrier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49864   Cascade
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49865   Cassette
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49866   Caster
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50344   Catheter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50345   Cautery
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49867   Cell
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49868   Charger
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49869   Chassis
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49870   Choke
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49871   Circuit board
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50347   Circuit Breaker
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49872   Clamp
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49873   Clip
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49874   Clock
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C53997   CO2 monitor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49875   CO2 monitor subassembly (only use when part of another device)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49876   Coder
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49877   Coil
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49881   Collimator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49882   Comparator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50129   Compressor (air pump)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C61402   Computer Hardware
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C61403   Concentrate
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49883   Concentrator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49878   Conductor coil
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49884   Connecting rod
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49885   Connector
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50295   Connector Pin
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50031   Contact lens
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50204   Control switches
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49887   Controller
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49888   Converter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50319   Cooling module                                                     Cooling System
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49890   Cord
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49893   Core
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49894   Counter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50352   Counterbalance
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49895   Coupler
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49896   Cover
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50332   CPU (central processing unit of computer system)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49897   CPU (central processing unit) board
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49898   Crank arm assembly
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50238   CRT (cathode ray tube)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49899   Crystal
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49900   Cuff
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50165   Cup seal
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49901   Cups
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49902   Current limiter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49903   Current source
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49904   Cusp
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49905   Cutter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50342   Cutter-Torque Cable
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49906   Cylinder
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50259   Cylinder valve
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49907   Damper
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50241   Data acquisition unit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49908   Decoder
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49909   Defibrillator paddles
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49910   Defibrillator subassembly (only use when part of another device)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49911   Dehumidifier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49912   Dehydrator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50353   Deionizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49913   Delay line
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49914   Demagnetizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49915   Demodulator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50055   Densitometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49916   Detector
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49755   Device Component or Accessory
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49918   Device deployer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C53996   Device Subassembly
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49919   Dial
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49920   Diaphragm
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49921   Digitizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49922   Diode
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49924   Discrete component/device (resistor, capacitor, diode)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49925   Disk
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49927   Display
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49928   Divider
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49929   Dome
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49930   Doubler
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49931   Driver
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49932   Duct
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49933   Dummy load
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49934   Duplexer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50075   EKG/ECG monitor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49935   EKG/ECG subassembly (only use when part of another device)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50027   Electrical lead
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50336   Electrical Wire
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49936   Electrode
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50351   Electrode Contact
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50308   Emergency Stop Button or Switch
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50309   Emergency Table Stop
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49937   Emitter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49938   Enclosure
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49939   Encoder
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49940   Endoscope
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50338   Endoscopic Accessory
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50049   EPROM (erasable programmable read only memory)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49941   Equalizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49942   Evaporator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49957   Exhalation filter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49943   Expander
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49944   Extender
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50359   External Fiberoptic
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49945   Extractor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49946   Eyelet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50208   Fail-safe system
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49947   Fan
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49948   Fastener
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49949   Feedthru
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49950   Ferrule
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49951   FET (field effect transistor)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49952   Fiber
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50362   Fiberguide
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50358   Fiberoptic
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50348   Fiberoptic Cladding
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50349   Fiberoptic Cleaver
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49955   Film
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C69444   Film Processor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49956   Filter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49959   Flange
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49960   Flasher
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50054   Flowmeter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49961   Foil
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49962   Foot pedal
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50202   Foot switch
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49963   Frame
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50002   Function indicator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50284   Function Indicator Light
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49964   Function lid
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49965   Furnace
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49966   Fuse
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50314   Gas delivery system
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49967   Gas scavenging
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49968   Gasket
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50052   Gauges/meters                                                      Meter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49969   Gears                                                              Gear
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49970   Generator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49971   Grille
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49972   Grommet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49973   Ground strap
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49974   Guide
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50271   Guidewire
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50281   Hand immobilizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50275   Handpiece
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50276   Handrest
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49977   Handset
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50277   Haptic
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49978   Header
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49979   Headphone
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49980   Heads
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49982   Headset
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49983   Heart valve cage
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50029   Heart valve leaflet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50150   Heart valve sewing ring
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49984   Heat exchanger
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49985   Heat sink
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49986   Heater
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49987   Heater rod
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49880   Helifix coil
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50335   Hemo Valve
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50302   Hermetic Seal
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49988   Hinge
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49989   Holder
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49953   Hollow fiber
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50279   Hose
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50280   Hose Line
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49990   Housing
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49991   Hub
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49992   Humidifier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49993   Hybrid circuit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50313   Hydraulic Bed System
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50312   Hydraulic System
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49994   IC (integrated circuit)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49995   IC (integrated circuit) chip
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49996   Igniter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49997   Imager
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49998   Impedance converter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50000   Indexer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50001   Indicator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50003   Inductor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50316   Injection System                                                Injector system
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50004   Insulation
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50005   Integrator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50006   Intercom
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50007   Interconnection board intubate
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50008   Interface
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50009   Interrupter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50298   Intravenous Pole
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50010   Inverter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49999   IOL (intraocular lens) implant
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50011   Isolator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50012   Jack
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C54020   Jaw
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50013   Joint
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50015   Joystick
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50016   Jumper
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50017   Junction
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50018   Keyboard
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50019   Keyer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50020   Keypad
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50021   Kit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C54021   Knife
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50022   Knob
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50023   Label
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50024   Laminate
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50025   Lamp
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50026   Laser
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50292   Laser nozzle
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C54022   Latch
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50282   Lead
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50028   Lead conductor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50326   Lead Tip
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50283   Leaflet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50357   Leaflet Disk
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49923   LED (light emitting diode)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50030   Lenses
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50201   Limit switch
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50032   Limiter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50033   Line conditioner
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49840   Lithium iodide battery
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50034   Load
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50035   Lock
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50286   Locking mechanism
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50036   Locking sleeve
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50287   Lockout Mechanism
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50037   Logic board
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50038   Lower piston bearing
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50260   Luer valve
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50039   Magazine
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50040   Magnet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50041   Magnetizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50053   Magnetometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50042   Magnetoresistor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50043   Magnifier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50044   Manifold
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50045   Matrices
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50285   Mechanism
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50046   Membrane
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50047   Memory
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50082   Meter needle
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50067   Microcircuit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50068   Microphone
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50069   Microscope
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50070   Mirror
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50071   Mixer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50072   Modem
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50073   Modulator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50074   Monitor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50076   Mother board
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50355   Motion Detector
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50077   Motor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50331   Motor Drive Unit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50103   Motor roll pin
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50079   Mount
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C54010   Multiplier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50080   Nebulizer (only use when part of another device)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50290   Needle
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50081   Network
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50083   None
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50291   Nozzle
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50325   Nozzle Tip
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50084   Nuts
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50085   O2 monitor subassembly (only use when part of another device)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50168   O2 sensor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50086   Obturator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50334   One-Way Valve
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49856   Optical cable
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49926   Optical disk
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49954   Optical fiber
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50087   Optocoupler
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50088   Oscillator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50089   Oscilloscope
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50091   Outlet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50092   Oven
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50093   Overlay
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50065   Oximeter (only use when part of another device)   Oximeter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50094   Oxygen analyzer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50095   Pad
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50293   Pallet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50096   Panel
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50097   PC (printed circuit) board
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49917   Photodetector
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50098   Photomultiplier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50328   Photomultiplier (PM) Tube
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50099   Phototransistor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50100   Pickup
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50261   Pilot balloon valve
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50101   Pin
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50296   Pipette
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49975   Piston guides
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49981   Piston heads
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50104   Piston Pads
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50105   Pivot
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50106   Plate
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50107   Plotter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50108   Plug
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50297   Plunger
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50109   Pointer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50110   Polarizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50111   Port
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50112   Post
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50064   Potentiometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49892   Power cord
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50113   Power lamp
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50114   Power module
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50115   Power supply
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50200   Power switch
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50116   Preamplifier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50117   Prescaler
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50118   Preselector
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50167   Pressure sensor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50119   Pressure signal
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50239   Pressure tubing
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50120   Printer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50121   Probe
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50299   Probe, Transducer Pressure
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50122   Processor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50123   Programmer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50050   PROM (programmable read only memory)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50124   Prong
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50125   Protector
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50203   Proximity switch
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50126   Pulley
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50127   Pulser
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50128   Pump
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C54023   Pusher
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50063   Pyrometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50130   Rail
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50051   RAM (random access memory)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50303   Rate modulated pacing sensor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50131   Reactor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50132   Reader
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50133   Receiver
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50330   Receiver Stimulator Unit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50134   Recorder (tape, stripchart, etc.)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50135   Rectifier
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50136   Reed (electrically open)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50137   Regulator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50138   Relay
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50139   Repeater
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50140   Reservoir
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50141   Resistor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50143   Resonator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50144   Retainer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50102   Retaining pin
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50145   Reticle
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50146   Rheostat
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50147   Ribbon
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50148   Ring
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50151   Rivet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50152   Robot
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50153   Rod
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50048   ROM (read only memory)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50154   Safety interlock
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50155   SAW (surface acoustic wave device)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50156   Scale
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50157   Scaler
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50158   Scanner
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50062   Scintillometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50159   Scrambler
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50160   Screen
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50161   Screw
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50278   Screw Head
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50321   Screw Tapper
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50162   Scriber
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50163   Seal
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50164   Seal tracheal
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50360   Sediment Filter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50166   Sensor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50169   Servo
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50170   Shaft
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50171   Shield
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50172   Shift register
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50173   Shifter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50305   Shoulder Support
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50174   Shunt
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50175   Shutter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50301   Side Rail
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50176   Signal conditioner
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50177   Simulator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50178   Slide
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50149   Slip ring
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50179   Slotter line
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50180   Socket
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49809   Socket adaptor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50014   Solder joint
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50181   Solenoid
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49805   Sound absorber
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50182   Spacer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50183   Spark gap
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50184   Speaker
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50061   Spectrometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50306   Speech Processor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50066   Spirometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50185   Splicer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50186   Spooler
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50187   Spring
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50288   Spring Loading Mechanism
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50188   Stabilizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50189   Stand
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50307   Staple
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50337   Steering Wire
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50190   Stent
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50078   Stepper motor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50191   Stiffener
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50192   Stopcock
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50333   Stopcock Valve
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50193   Strain relief
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50194   Strip line
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50195   Stylet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50196   Substrate
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50197   Sunlamp
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50198   Suppressor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50364   Surgical Graft
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50365   Suture
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C54013   Switch, push button
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50199   Switches
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50205   Synchronizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50206   Synthesizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50207   Syringe
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50310   Syringe Drive
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50311   System
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50371   Table
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50320   Table Top
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50060   Tachometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50209   Tape
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50210   Tee
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50211   Telemetry equipment
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50212   Telephone
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50213   Teleprinter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50214   Teletypewriter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50242   Television unit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50215   Temperature compensator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50300   Temperature Probe
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50304   Temperature sensor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50216   Terminal
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50217   Terminal assembly
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50218   Terminator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50322   Test Strip
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50219   Thermistor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50220   Thermocouple
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50270   Thermocouple wire
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50059   Thermometer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50221   Thermostat
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50323   Thread
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50222   Thyristor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50223   Timer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50324   Tip
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49879   Tip conductor coil
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50294   Tomographic Pallet
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50350   T-piece connector
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50224   Trackball
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50225   Transceiver
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50226   Transducer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50227   Transformer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50228   Transistor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50229   Translator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50230   Transmission line
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50231   Transmitter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50232   Transponder
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50233   Transport
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50234   TRIAC                                                                                              Three Terminal Current Controlling Semiconductor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50235   Trimmer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50327   Trocar
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50236   Tube
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50237   Tube capillary
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50240   Tuner
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50329   Unit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C54008   User interface
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50243   Valve                                                                                              Valve (one-way, hemo, stopcock, etc.)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C54016   Valve cam
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50244   Valve, control
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50245   Valve, directional
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50246   Valve, dump
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50247   Valve, exhalation
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50248   Valve, flap
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50249   Valve, flow
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50250   Valve, inhalation
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50251   Valve, inlet port
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50252   Valve, inspiratory
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50253   Valve, outlet port
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50254   Valve, PEEP (positive end expiratory pressure)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50255   Valve, pressure limit
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50256   Valve, relief
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50257   Valve, safety
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50258   Valve, selector
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50262   Vaporizer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50263   Varistor
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50264   VDT (video display terminal)
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50265   Vibrator
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50266   Viewer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50058   Voltmeter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50267   Washer
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50315   Water Purification System
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49976   Waveguide
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50361   Wedge Filter
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C51067   Wheel
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C51069   Wheelchair, Tires
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C51068   Wheelchair, Wheels
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50268   Window
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50269   Wire
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50272   Wiring harness
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C50273   Yoke
FDA   C54577   Medical Device Component Or Accessory Terminology FDA CDRH   C49886   Y-piece connector
FDA   C54451   Medical Device Problem Codes FDA CDRH                        C63281   Aborted charge                                        Issue associated with the spontaneous         Charge, aborted
                                                                                                                                           ending of the charging process in relation to
                                                                                                                                           the apparent surface voltage present on an
                                                                                                                                           electrostatic recording medium.
FDA   C54451   Medical Device Problem Codes FDA CDRH                        C63036   Accessory incompatible                                                                              Accessories, incompatible
FDA   C54451   Medical Device Problem Codes FDA CDRH                        C63312   Accidental spillage                                   Issue associated with the unexpected          Spillage, accidental
                                                                                                                                           flowing or pouring of liquids, gas or air
                                                                                                                                           substances into the device or environment in
                                                                                                                                           which the device is being used.

FDA   C54451   Medical Device Problem Codes FDA CDRH                        C63034   Advancement issue                                     Issue associated with the forward movement
                                                                                                                                           of the device and/or device components to
                                                                                                                                           an intended location.
FDA   C54451   Medical Device Problem Codes FDA CDRH                        C63311   Air leak                                                                                           Air leak(s)
FDA   C54451   Medical Device Problem Codes FDA CDRH                        C63309   Alarm not visible
FDA   C54451   Medical Device Problem Codes FDA CDRH                        C63308   Ambient noise issue                                  Issue associated with any undesired
                                                                                                                                          acoustic energy or vibration that tends to
                                                                                                                                          interfere with the operation of the device.
FDA   C54451   Medical Device Problem Codes FDA CDRH                        C63307   Ambient temperature issue                            Issue associated with the thermal state in
                                                                                                                                          the immediate environment in which a
                                                                                                                                          device is being used.
FDA   C54451   Medical Device Problem Codes FDA CDRH                        C63306   Application interface becomes non-functional or program exits abnormally                           Crash or lock-up
FDA   C54451   Medical Device Problem Codes FDA CDRH     C64349   Application network issue                               Issue associated with the deviations from
                                                                                                                          documented system specifications that
                                                                                                                          affects overall system performance and/or
                                                                                                                          the performance of an individual device or
                                                                                                                          collection of devices connected to that
                                                                                                                          system.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63032   Application problems                                    Issue associated with difficulties in attaching
                                                                                                                          a device to another object including another
                                                                                                                          device or device component or to a patient
                                                                                                                          body part.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63305   Application program issue                               Issue associated with the requirement for
                                                                                                                          software to fulfill its function within an
                                                                                                                          intended use or application.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63304   Application program version or upgrade problem
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63042   Application security issue                              Issue associated with the acquisition of    Computer virus infection
                                                                                                                          computer programming codes that can
                                                                                                                          replicate and spread from one computer
                                                                                                                          system to another thereby leading to
                                                                                                                          damaged software, hardware and data.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63301   Arcing                                                  Issue associated with arc strikes
                                                                                                                          characterized by localized burn damage to a
                                                                                                                          part from an arc caused by making or
                                                                                                                          breaking an energized electrical circuit.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63303   Arcing at electrodes
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63302   Arcing at paddles
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63300   Artifact                                                Issue associated when an extrinsic agent,
                                                                                                                          method or image produces any item
                                                                                                                          (display, suspension etc) that is not naturally
                                                                                                                          present.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63299   Aspiration issue
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63297   Bacterial contamination of device                                                                         Bacterial contamination|Contamination, bacterial
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C64334   Battery impedance issue
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63030   Battery issue
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63296   Bent                                                    Issue associated with the change in angle of Bend material|Bent Material
                                                                                                                          a material as a function of steadily applied
                                                                                                                          forces.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63294   Biocompatibility issue
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63293   Biofilm coating in device                                                                                 Biofilm coating
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63292   Biological environmental factor
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63290   Bleed back
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63289   Blockage within device or device component                                                             Blockage
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63288   Blocked connection                                      Issue associated with linking of device
                                                                                                                          and/or device components whereby their
                                                                                                                          functional units set up to provide means for
                                                                                                                          a transfer of fluid, gas, or data is prevented
                                                                                                                          or impeded.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62973   Break                                                   Issue associated with undesired damage or Material break|Device breakage
                                                                                                                          breakage of those materials used in device
                                                                                                                          construction.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63287   Buckled material                                        Issue associated with an undesired bulge,
                                                                                                                          bend, bow, kink, or wavy condition observed
                                                                                                                          in the device material resulting from
                                                                                                                          compressive stresses.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63286   Burn of device or device component                      Issues associated with a discoloration or      Burn|Burnt|Burned
                                                                                                                          destruction as a result of thermal
                                                                                                                          decomposition of the material used for the
                                                                                                                          device construction. (Adapted from 10th ed.
                                                                                                                          ASTM Dictionary of Engineering Science
                                                                                                                          and Technology D3918, D20 page 77.)

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62972   Burst                                                   Issue associated with an undesired open           Material burst
                                                                                                                          breakage in the materials that are used in
                                                                                                                          device construction.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63285   Calcified                                               Issue associated with the gradual decrease        Calcification|Calcified material
                                                                                                                          in the efficiency of the device comprising
                                                                                                                          material(s) impregnated with calcium salts
                                                                                                                          and deposition of calcareous material.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63284   Calibration error                                                                                         Miscalibration
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63028   Calibration issue                                       Issue associated with the comparison of a
                                                                                                                          measurement system or device of unverified
                                                                                                                          accuracy to a measurement system or
                                                                                                                          device of unknown and greater accuracy, to
                                                                                                                          detect and correct any variation from
                                                                                                                          required performance specifications of the
                                                                                                                          measurement of the system or device.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63283   Capacitive coupling
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63027   Capturing issue                                   Issue associated with the inability of device
                                                                                                                    and/or device components to achieve
                                                                                                                    successful depolarization and contraction of
                                                                                                                    a cardiac chamber caused by a pacemaker
                                                                                                                    output pulse.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63282   Changes in ambient temperature in device environment                                            Ambient temperature, changes in
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63026   Charging issue                                    Issue associated with the inability of device
                                                                                                                    and/or device components to successfully
                                                                                                                    charge an electrical source.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63279   Charred
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62945   Chemical issue                                    Issue associated with any deviations from
                                                                                                                    device documented performance
                                                                                                                    specifications relating to any chemical
                                                                                                                    characterization, i.e., element, compound, or
                                                                                                                    mixture.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63278   Chemical spillage                                 Issue associated with unintentional pouring
                                                                                                                    out or releasing of chemical substances.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63277   Circuit Failure                                         Issue associated with the electrical network
                                                                                                                          paths on a physical medium, e.g. a circuit
                                                                                                                          board where the signals fail to be conducted
                                                                                                                          across two or more connected points.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63276                                                           Issue associated with the undesired
                                                                  Cleaning disinfecting or sterilization problem during device use
                                                                                                                          introduction of impurities to a device, or the
                                                                                                                          insufficient removal of any visible soil, foreign
                                                                                                                          material or organism deposits on the
                                                                                                                          external surfaces, crevices, and joints of a
                                                                                                                          device by a mechanical and/or manual
                                                                                                                          process intended to render the device
                                                                                                                          sterile, safe for handling, and/or for further
                                                                                                                          processes to decontaminate.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63275   Clumping in device or device ingredient                 Issue associated with the aggregation of          Clumping
                                                                                                                          particles, such as bacteria, into irregular
                                                                                                                          masses.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63274   Coagulation in device or device ingredient              Issue associated with the undesired               Coagulation
                                                                                                                          characterization of congealing, solidifying,
                                                                                                                          thickening, curdling.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63273   Coiled
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63272   Collapse                                                Issue associated with the buckling or
                                                                                                                          crushing of material from external forces.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63271   Communication or transmission issue                     Issue associated with any deviations from
                                                                                                                          device documented performance
                                                                                                                          specifications relating to the signal
                                                                                                                          structures and information exchanges
                                                                                                                          between integrated circuits and terminal
                                                                                                                          interfaces both intra and interoperationally.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63153   Component falling                               Issue associated with an undesirable              Component(s) falling
                                                                                                                  descent of a device component due to the
                                                                                                                  force of gravity, usually from a higher to a
                                                                                                                  lower level, usually the ground or floor.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63022   Component incompatible                                                                            Component(s), incompatible
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63021   Component missing                               Issue associated with the absence of any          Components, missing
                                                                                                                  part, substance, software, hardware, or raw
                                                                                                                  material that is designed to be put together
                                                                                                                  as part of the finished device or product.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63020   Component or accessory incompatibility          Issue associated with the incompatibility of
                                                                                                                  any device and/or device components while
                                                                                                                  being operated in the same use environment
                                                                                                                  thereby leading to a dysfunction between the
                                                                                                                  device and its components.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63270   Computer operating system issue                 Issue associated with the machinery
                                                                                                                  operating system, a collection of software,
                                                                                                                  firmware, and hardware elements that
                                                                                                                  control the execution of computer programs
                                                                                                                  and provides such services as computer
                                                                                                                  resource allocation, job control, input/output
                                                                                                                  control, and file management in a computer
                                                                                                                  system.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63269   Computer software issue                         Issue associated with any deviations from      Computer software error
                                                                                                                  device documented performance
                                                                                                                  specifications relating to written programs,
                                                                                                                  codes, and/or software system that provide a
                                                                                                                  capability to satisfy a stated need or
                                                                                                                  objective which combines with one or more
                                                                                                                  of the following: installation, software
                                                                                                                  components, process, hardware, facilities
                                                                                                                  and people.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C64348   Computer system security issue
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63267   Confusing instruction for device use            Issue associated with users being unclear
                                                                                                                  and not able to follow any written, printed, or
                                                                                                                  graphic matter that is affixed to a medical
                                                                                                                  device or its containers, wrappers; with any
                                                                                                                  matter that accompanies a medical device
                                                                                                                  including verbal instructions related to
                                                                                                                  identification, technical description and use
                                                                                                                  of the medical device provided by the device
                                                                                                                  manufactures that vary from the standard of
                                                                                                                  medical care in a given environment.


FDA   C54451   Medical Device Problem Codes FDA CDRH     C62952   Connection issue                                Issue associated with linking of device
                                                                                                                  and/or device components and/or the
                                                                                                                  functional units set up to provide means for
                                                                                                                  a transfer of fluid, gas, or data.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63018   Contamination during use                        Issue associated with the undesired             Contamination
                                                                                                                  introduction of impurities either chemical or
                                                                                                                  microbiological in nature, or of foreign matter
                                                                                                                  into or onto the device at the user facility.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63266   Contamination of device ingredient or reagent
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63265   Continuous firing                               Issue associated with the excessive
                                                                                                                  production of electrical impulses over a
                                                                                                                  period.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63263   Corrosion                                       Issue associated with the chemical or         Corrode|Corroded
                                                                                                                  electrochemical reaction between materials,
                                                                                                                  usually a metal and its environment that
                                                                                                                  produces a deterioration of the metal and its
                                                                                                                  properties.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62971   Crack                                           Issue associated with an undesired            Crack(s)|Material crack
                                                                                                                  separation and/or a visible opening along
                                                                                                                  the length or width in the materials that are
                                                                                                                  used in device construction.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63261   Cross reactivity                                Issue associated with the degree to which
                                                                                                                  an antibody or antigen participates in cross
                                                                                                                  reactions.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63260   Cut in material                                                                               Cut|Cut(s)
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63258   Data back-up problem                            Issue associated with problems relating to a
                                                                                                                  system, component, file, procedure, or
                                                                                                                  person available to replace or help restore a
                                                                                                                  primary item in the event of a failure or
                                                                                                                  externally caused disaster.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63257   Data corrupted
FDA   C54451   Medical Device Problem Codes FDA CDRH     C67508   Date-related problem, not year 2000 (Y2K)       Issue associated with programming of
                                                                                                                  calendar dates and/or time as a factor in the
                                                                                                                  operation of a medical device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63256   Decoupling                                      Issue associated with the device and/or
                                                                                                                  device components being un-associated in
                                                                                                                  such a way that fluid, gas, power or signal
                                                                                                                  information may not be transferred from one
                                                                                                                  to another.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63255   Decrease in pressure                                                                         Pressure, decrease in
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63254   Decrease in suction                             Issue associated with the removal by suction Aspiration, incomplete|Incomplete aspiration|Suction, decrease in
                                                                                                                  of excess fluid or gas from a body cavity.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63252   Decreased pump speed                                                                              Pump speed, decreased
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63253   Decreased sensitivity                                                                             Sensitivity, decreased
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63251   Defective Alarm                                                                                   Alarm, defective
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63023   Defective component                             Issue associated with a device component          Components, defective
                                                                                                                  having flaws of dimensional deviations
                                                                                                                  greater than acceptable for the intended
                                                                                                                  use.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63250   Defective item                                  Issue associated with having flaws or             Device, defective
                                                                                                                  dimensional deviations greater than
                                                                                                                  acceptable for the intended use of the
                                                                                                                  device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63249   Deflation issue                                 Issue associated with the inability of device     Deflation difficulties
                                                                                                                  and/or device components to release gas or
                                                                                                                  air.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62970   Degraded                                        Issue associated with a deleterious change        Material degradation
                                                                                                                  in the chemical structure, physical
                                                                                                                  properties, or appearance in the materials
                                                                                                                  that are used in device construction.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C50433   Delamination                                    Issue associated with peeling of composite
                                                                                                                  materials. Occurs when layers are separated
                                                                                                                  as a result of continuous stress or impact.
                                                                                                                  Results in loss of mechanical toughness.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63247   Delayed alarm                                                                                  Alarm, delayed
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63280   Delayed charge time                                                                            Charge times, delayed
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63014   Delivered as unsterile product                  Issue associated with the delivery of a device Nonsterility
                                                                                                                  and/or device component that has any viable
                                                                                                                  organism, either active or dormant, thereby
                                                                                                                  compromising the device's sterility.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63246   Delivery system failure
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63245   Dent in material                                                                                  Dent
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63013   Deployment issue                                    Issue associated with any deviations from
                                                                                                                      device documented performance
                                                                                                                      specifications relating to the sequence of
                                                                                                                      events for activation and positioning of a
                                                                                                                      module to a specific location, e.g. for
                                                                                                                      interventional stenting, optimal deployment
                                                                                                                      can be defined as the stent being fully
                                                                                                                      opened along the length of the stent and
                                                                                                                      embedded in the arterial tissue or pathology.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63243   Detachment of device component                                                                      Component(s), detachment of|Device component detached
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63242   Detachment of device or device component            Issue associated with the separation of the     Device or device component detached
                                                                                                                      device and/or device components from its
                                                                                                                      physical construct, integrity, or chassis.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63037   Device abrasion from instrument or another object                                                 Abrasion from instrument/object
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63033   Device alarm system issue                           Issue associated with electrical equipment or Alarm failure|Alarm, failure to
                                                                                                                      a system that detects alarm conditions (a
                                                                                                                      state of the alarm system when it has
                                                                                                                      determined that a potential or actual hazard
                                                                                                                      exists) and, as appropriate, generates alarm
                                                                                                                      signals.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63024   Device clogged                                                                                    Clogged
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63017   Device Contamination with biological material
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63016   Device contamination with blood or blood product                                                    Blood contaminated device
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63015   Device damaged prior to use                                                                         Damage, internal/external|Damaged item|Item damaged prior to use
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63010   Device difficult to prepare                         Issue associated with the use of the device     Prep, difficult to
                                                                                                                      in terms of user experiencing difficulty in
                                                                                                                      preparing the device for use, even if the
                                                                                                                      operation is being performed according to
                                                                                                                      labeled instructions for use.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63008   Device disinfection or sterilization issue
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63004   Device emits odor
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62998   Device expiration issue                             Issue associated with the expiration date or    Expiration date exceeded
                                                                                                                      shelf life of a product.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62984   Device flammable                                                                                    Flammable
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62982   Device ingredient or reagent issue
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62979   Device inoperable                                   Issue associated with the device being in a Device, inoperable
                                                                                                                      nonfunctional or inoperable state and cannot
                                                                                                                      be used unless the causes of the
                                                                                                                      inoperability are located and fixed.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62996   Device Issue                                                                                       Malfunction|Device failure
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62977   Device maintenance issue                            Issue associated with the servicing of a       Maintain, failure to
                                                                                                                      device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62975   Device marking unclear                              Issue associated with the clarity of any
                                                                                                                      written, printed or graphic material that is
                                                                                                                      affixed to a medical device or any of its
                                                                                                                      containers or wrappers or accompanying the
                                                                                                                      device including verbal instructions, relating
                                                                                                                      to identification, technical description, and
                                                                                                                      usage which are provided by the device
                                                                                                                      manufacturers.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62976   Device markings issue
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62974   Device markings worn out                           Issue associated with the aging or wear of
                                                                                                                     any written, printed or graphic material that
                                                                                                                     is affixed to a medical device or any of its
                                                                                                                     containers or wrappers or accompanying the
                                                                                                                     device including verbal instructions, relating
                                                                                                                     to identification, technical description, and
                                                                                                                     usage which are provided by the device
                                                                                                                     manufacturers.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62957   Device misassembled during manufacturing or shipping
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62955   Device operates differently than expected          Issue associated with any deviations from
                                                                                                                     expected performance while operating and
                                                                                                                     using the device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62954   Device operational issue                           Issue associated with any deviations from
                                                                                                                     specifications relating to device operations in
                                                                                                                     terms of, deployment, connection, electrical,
                                                                                                                     computer software, infusion/flow, output,
                                                                                                                     protective-measure, and incompatibility
                                                                                                                     issues.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62951                                                      Issue
                                                                  Device or device component damaged by another device associated with the mechanical action
                                                                                                                     of one material scratching and grinding
                                                                                                                     another material between two or more
                                                                                                                     devices.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C64341   Device or device component incrementation issue
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63038   Device or device fragments location unknown                                                        Device/device fragments, unknown location of
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62946   Device or device fragments remain in patient       Issue associated with the inability to retrieve
                                                                                                                     device and/or device fragments during
                                                                                                                     medical procedures.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63240   Device packaging compromised                       Issue associated with the non-conformance
                                                                                                                     to device specifications and minimum
                                                                                                                     packaging requirements as the device may
                                                                                                                     not be operating and functioning as
                                                                                                                     intended.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62931   Device remains activated                           Issue associated with the occurrence of a
                                                                                                                     signal line making a transition from its
                                                                                                                     inactivated state to its active state and
                                                                                                                     remains in this state when it is not expected
                                                                                                                     to.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63238   Device sensing issue                               Issue associated with device features that
                                                                                                                     are designed to respond to a physical
                                                                                                                     stimulus (temperature, illumination, motion,
                                                                                                                     cardiac rhythms) that do not transmit a
                                                                                                                     resulting signal for interpretation or
                                                                                                                     measurement.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62927   Device setting does not match patient condition    Issue associated with mismatch between the
                                                                                                                     default or most obvious device setting and
                                                                                                                     the patient anatomical and/or physiological
                                                                                                                     characteristics (e.g. adult device on pediatric
                                                                                                                     patient).
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62924   Device stops intermittently                        Issue associated with any deviation from
                                                                                                                     device document specification relating to the
                                                                                                                     irregular rate at which the device stops.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C73118   Device Unsafe to Use in Environment
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63236   Device-device incompatibility                       Issue associated with the incompatibility of
                                                                                                                      two or more devices while being operated in
                                                                                                                      the same use environment thereby leading
                                                                                                                      to a dysfunction of more than one device.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63035   Difficult or delayed activation                                                                     Activation, difficult /delayed|Activation, difficult or delayed
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63235   Difficult to advance                                Issue associated with the difficulty to see a
                                                                                                                      forward movement of the device and/or
                                                                                                                      device components to an intended location.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63244   Difficult to deploy                                 Issue associated with users experiencing        Deploy, difficult to
                                                                                                                      difficulty or uneasiness to deploy device
                                                                                                                      and/or device components to a specified
                                                                                                                      location.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63317   Difficult to flush                                                                                  Flush, difficult to
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63234   Difficult to fold or unfold                         Issue associated with the use of the device     Fold, difficult to
                                                                                                                      in terms of user experiencing difficulty to
                                                                                                                      close or to spread out/extend length of a
                                                                                                                      device, even if the operation is being
                                                                                                                      performed according to labeled instructions
                                                                                                                      for use.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63233   Difficult to insert                              Issue associated with the use of the device Insertion difficulties
                                                                                                                 in terms of user experiencing difficulty to
                                                                                                                 introduce or to intervene with a device and/or
                                                                                                                 device components, even if the operation is
                                                                                                                 being performed according to labeled
                                                                                                                 instructions for use.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63232   Difficult to interrogate                         Issue associated with difficulty of a          Interrogate, difficult to
                                                                                                                 transponder system to trigger a response.

FDA   C54451   Medical Device Problem Codes FDA CDRH   C63012   Difficult to open or close                       Issue associated with the use of the device
                                                                                                                 in terms of user experiencing difficulty
                                                                                                                 opening and closing the device, even if the
                                                                                                                 operation is being performed according to
                                                                                                                 labeled instructions for use.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63231   Difficult to open or remove packaging material   Issue associated with difficulty for end-users
                                                                                                                 to operate device, specifically as it relates to
                                                                                                                 the opening or removal of the outer
                                                                                                                 wrapping.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63230   Difficult to position                            Issue associated with the use of the device Positioning difficulties
                                                                                                                 in terms of user experiencing difficulty to put
                                                                                                                 device and/or device components in place,
                                                                                                                 even if the operation is being performed
                                                                                                                 according to labeled instructions for use.

FDA   C54451   Medical Device Problem Codes FDA CDRH   C64339   Difficult to program                                                                            Program, difficult to
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63228   Difficult to remove                              Issue associated with the use of the device Removal difficulties
                                                                                                                 in terms of user experiencing difficulty to
                                                                                                                 take out or get rid of a device and/or device
                                                                                                                 components, even if the operation is being
                                                                                                                 performed according to labeled instructions
                                                                                                                 for use.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63009   Difficult to use or set up                       Issue associated with user experiencing
                                                                                                                 difficulty in setting up, preparing and/or
                                                                                                                 using the device.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63226   Difficult to wedge                               Issue associated with the use of the device Wedge, difficult to
                                                                                                                 in terms of user experiencing difficulty to
                                                                                                                 mold into a triangular cross-section of device
                                                                                                                 and/or device components, even if the
                                                                                                                 operation is being performed according to
                                                                                                                 labeled instructions for use.

FDA   C54451   Medical Device Problem Codes FDA CDRH   C63225   Disassembly
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63223   Disconnection                                    Issue associated with the linking of device     Broken Connection|Disconnect
                                                                                                                 and/or device components having a
                                                                                                                 sufficient open space to prevent gas, liquid
                                                                                                                 or electrical current flow between
                                                                                                                 connectors.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C62950   Dislodged or dislocated                          Issue associated with mechanical force that Dislocated|Dislodged
                                                                                                                 displaces device and/or device components
                                                                                                                 from an intended location.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63221   Display misread                                  Issue associated with not correctly reading
                                                                                                                 the patient or test result information provided
                                                                                                                 by the device.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63220   Dose calculation error due to software problem                                                   Dose calculation error
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63219   Dull
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63007   Electrical issue                                 Issue associated with any deviations from       Device electrical issue|Electrical failure
                                                                                                                 device documented performance
                                                                                                                 specifications relating to electrical processes
                                                                                                                 of a device and/or device components that
                                                                                                                 have an applied part or transferred energy to
                                                                                                                 and from the patient or detect such energy
                                                                                                                 transfer to or from the patient.

FDA   C54451   Medical Device Problem Codes FDA CDRH   C63218   Electrical overstress                            Issue associated with an electrical activity
                                                                                                                 that exceeded the specified threshold limit of
                                                                                                                 the internal integrated circuitry.

FDA   C54451   Medical Device Problem Codes FDA CDRH   C63217   Electrical power problem                         Issue associated with the facility-supplied
                                                                                                                 power supply or electrical energy, including
                                                                                                                 batteries that provide power for the parent
                                                                                                                 device or power to run auxiliary functions,
                                                                                                                 e.g., alarms or memory.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63006   Electrical resistance issue                      Issue associated with the occurrence at
                                                                                                                 which the ratio of voltage applied to a current
                                                                                                                 flowing in a body, i.e., resistance, neglects
                                                                                                                 capacitative and inductive effects.

FDA   C54451   Medical Device Problem Codes FDA CDRH   C63216   Electrical shorting
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63215   Electromagnetic compatibility issue              Issue associated with the ability of a system
                                                                                                                 to function in its electromagnetic
                                                                                                                 environment without introducing intolerable
                                                                                                                 disturbances to anything in its environment.

FDA   C54451   Medical Device Problem Codes FDA CDRH   C63214   Electro-magnetic interference (EMI)              Issue associated with a measure of                 EMI
                                                                                                                 electromagnetic radiation from equipment.

FDA   C54451   Medical Device Problem Codes FDA CDRH   C63005   Electronic property issue                        Issue associated with any deviations from
                                                                                                                 device documented performance
                                                                                                                 specifications relating to devices, circuits, or
                                                                                                                 systems utilizing electrons and in
                                                                                                                 association with components to convert,
                                                                                                                 control and condition of electric power
                                                                                                                 (alternating or direct current), and of voltage
                                                                                                                 and current.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63213   Electro-static discharge                         Issue associated with the discharge of
                                                                                                                 electricity between two bodies previously
                                                                                                                 electrically charged.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63212   Emergency power failure                          Issue associated with the failure of the
                                                                                                                 facility's emergency power backup
                                                                                                                 systems(s) including generators and/or
                                                                                                                 uninterruptible power systems (UPS).
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63001   Energy output to patient tissue incorrect
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63000   Energy spectrum incorrect
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63210   Entrapment of device or device component         Issue associated with the device and/or        Entrapment
                                                                                                                 device accessories caught within patient
                                                                                                                 vasculature or tissue.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63209   Environmental control or utility issue           Issue associated with the surrounding
                                                                                                                 conditions in which the device is being used
                                                                                                                 such as temperature, noise, lighting,
                                                                                                                 ventilation, or other external factors such as
                                                                                                                 power supply.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C72674   Environmental Particulates                       Issue associated with fine solids or liquid
                                                                                                                 particles such as dust, smoke, fume, and/or
                                                                                                                 mist suspended in the immediate
                                                                                                                 atmosphere in which the device is being
                                                                                                                 used.
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63207   Erratic display                                                                                 Display, erratic
FDA   C54451   Medical Device Problem Codes FDA CDRH   C63205   Error message given                              Issue associated with device providing
                                                                                                                 messages relating to any deviations from
                                                                                                                 documented performance specifications in
                                                                                                                 software, hardware, and/or user interface.

FDA   C54451   Medical Device Problem Codes FDA CDRH   C63204   Escape
FDA   C54451   Medical Device Problem Codes FDA CDRH   C62882   Excess flow or overinfusion                                                                         Overdelivery|Overinfusion
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63202   Excessive cooling                    Issue associated with device or device part
                                                                                                       overcool in device active (working) or/and
                                                                                                       non-active (non-working) states. The
                                                                                                       concept does not refer to the problem
                                                                                                       resulted from ambient temperature.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63201   Excessive manipulation               Issue associated with the use of the device
                                                                                                       in terms of exceeding mechanical and
                                                                                                       operational techniques as being non-
                                                                                                       conforming to the device's intended use,
                                                                                                       specifications, procedure and process or
                                                                                                       service instructions and information provided
                                                                                                       by the device manufacturers.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63200   Exit block                           Issue associated with the identification of a
                                                                                                       conduction delay or failure immediately distal
                                                                                                       to a pacemaker site.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62999   Expiration date error                Issue associated with errors in identification
                                                                                                       of expiration date.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C50554   Expulsion                            Issue associated with the unintended
                                                                                                       ejection of device component materials.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C50557   Extrusion                            Issue associated with the unintended of
                                                                                                       projection of device component materials.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62808   Facilities issue                     Issue associated with the physical             User facility issue
                                                                                                       establishment and environment in which
                                                                                                       medical devices are transported, stored,
                                                                                                       processed, serviced or used within the user
                                                                                                       facility.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63199   Fail-safe design failure             Issue associated with the stated condition
                                                                                                       that the equipment will contain self-checking
                                                                                                       features, which will cause a function to
                                                                                                       cease in case of failure, malfunction, or
                                                                                                       drifting out of tolerance.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62997   Fail-safe mechanism issue
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62989   Failure of device to self-test       Issue associated with the incapability to
                                                                                                       perform any procedural examination by itself
                                                                                                       prior to use.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63198   Failure to advance                   Issue associated with the inability to see a Advance, failure to
                                                                                                       forward movement of the device and/or
                                                                                                       device components to an intended location.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63197   Failure to align                     Issue associated with a circuit, equipment,     Align, failure to
                                                                                                       or system whereby its functions fail to be
                                                                                                       properly synchronized or its relative positions
                                                                                                       properly oriented.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63196   Failure to analyze rhythm                                                            Rhythm, failure to analyze|Failure to diagnose rhythm|Rhythm, failure to diagnose
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62995   Failure to auto stop                 Issue associated with the inability of a device
                                                                                                       to turn itself off when the device is not in an
                                                                                                       operable condition.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63195   Failure to back-up                   Issue associated with the inability to backup Back-up, failure to
                                                                                                       or to retrieve a backed up version (corrupted
                                                                                                       file) of device data or system files.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62994   Failure to calibrate                 Issue associated with the performance of the Calibrate, failure to
                                                                                                       device to assure it complies with the
                                                                                                       appropriate specifications for precision and
                                                                                                       conforms to device standards.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62993   Failure to capture                   Issue associated with the failure to achieve Capture, failure to
                                                                                                       effective and consistent depolarization of the
                                                                                                       heart resulting from the electrical stimulus of
                                                                                                       the pacemaker.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63193   Failure to charge                    Issue associated with failure to register       Charge, failure to
                                                                                                       charge immediately after charging in relation
                                                                                                       to the apparent surface voltage present on
                                                                                                       an electrostatic recording medium.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63192   Failure to charge shock capacitors   Issue associated with the failure to convert
                                                                                                       electric energy into chemical energy within
                                                                                                       the cell or battery, (in shock capacitators).
                                                                                                       Note: this restoration of the active materials
                                                                                                       is accomplished by maintaining a
                                                                                                       unidirectional current in the cell or battery in
                                                                                                       the opposite direction to that during
                                                                                                       discharge; a cell or battery that is said to be
                                                                                                       charged is understood to be fully charged.


FDA   C54451   Medical Device Problem Codes FDA CDRH     C63191   Failure to conduct                   Issue associated with the inability of a device Conduct, failure to
                                                                                                       and/or device components to allow a current
                                                                                                       of electricity to pass or to conduct electricity
                                                                                                       continuously along an electrical path.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63190   Failure to convert rhythm                                                           Rhythm, failure to convert
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63189   Failure to convert to back-up                                                       Back-up, failure to convert to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63188   Failure to cut                                                                      Cut, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63187   Failure to cycle                     Issue associated with the occurrence of total Cycle, failure to
                                                                                                       time used to carry out a complete sequence
                                                                                                       of operations fails.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63186   Failure to deliver                                                                  Deliver, failure to
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63185   Failure to deliver countershock      Issues associated with the effective           Countershock, failure to deliver|Failure to countershock
                                                                                                       electromotive force within a system that fails
                                                                                                       to oppose the passage of current in a
                                                                                                       specified direction.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63184   Failure to deliver energy                                                           Energy, failure to deliver
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63183   Failure to deploy                    Issue associated with the inability of device Deploy, failure to
                                                                                                       and/or device components to be activated
                                                                                                       and positioned in a specified location.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63181   Failure to discharge                 Issue associated with the failure to see a         Discharge, failure to
                                                                                                       discontinuous movement of electrical
                                                                                                       charges through an insulating medium,
                                                                                                       initiated by electron avalanches and
                                                                                                       supplemented by secondary processes.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63180   Failure to disconnect                Issue associated with the linking of device        Disconnect, failure to
                                                                                                       and/or device components whereby the
                                                                                                       functional units set up to provide means for
                                                                                                       a transfer of liquid, gas, electricity, or
                                                                                                       information do not come apart, or
                                                                                                       disconnect, when expected.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63179   Failure to disinfect                                                                    Disinfect, failure to|Disinfection, inadequate/improper
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63178   Failure to dry                                                                          Dry, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63177   Failure to fire                                                                         Fire, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63176   Failure to flush                                                                        Flush, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63175   Failure to fold                                                                         Fold, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C64328   Failure to form staple
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63174   Failure to infuse                                                                    Infuse, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63173   Failure to interrogate               Issue associated with the inability of a device Interrogate, failure to
                                                                                                       and/or device components to interrogate by
                                                                                                       radar, by signal, or by a combination of
                                                                                                       signals necessary to trigger a response via
                                                                                                       transmitter and receiver interrogating
                                                                                                       system.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63172   Failure to obtain samples                                                            Samples, failure to obtain
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63171   Failure to osseointegrate            Issue associated with the failure to see direct Osseointegrate, failure to
                                                                                                       anchorage of an implant by the formation of
                                                                                                       bony tissue around the implant without the
                                                                                                       growth of fibrous tissue at the bone-implant
                                                                                                       interface.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63170   Failure to override rhythm                                                           Rhythm, failure to override
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63169   Failure to pace or properly pace           Issue associated with the inability of device     Pace, failure to
                                                                                                             and/or device components to generate a
                                                                                                             therapeutic simulated heart beat via
                                                                                                             electrical impulses once arrhythmia is
                                                                                                             detected.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62992   Failure to power-up                                                                          Power-up, failure to
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63168   Failure to prepare device                  Issue associated with the use of device           Prep, failure to
                                                                                                             characterized by unsuccessful attempts to
                                                                                                             make the device ready for use.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63167   Failure to prime                                                                             Prime, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63166   Failure to program                                                                           Program, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63165   Failure to pump                                                                              Pump, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63164   Failure to read input signal                                                                 Input signal, failure to read
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63241   Failure to recalibrate                                                                       Recalibrate, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63163   Failure to remove enzymatic cleaner                                                          Enzymatic cleaner, failure to remove
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62991   Failure to reset                                                                             Reset, failure to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63162   Failure to run on AC/DC                                                                      AC/DC, failure to run on
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62990   Failure to run on portable mode                                                              Portable mode, failure to run on
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63161   Failure to select signal                                                                     Signal, failure to select
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63160   Failure to sense                           Issue associated with the failure of a device     Sensing, none
                                                                                                             designed to respond to a physical stimulus
                                                                                                             (as temperature, illumination, motion) to
                                                                                                             transmit a resulting signal for interpretation
                                                                                                             or measurement.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63159   Failure to separate                        Issue associated with the inability of device Separate, failure to
                                                                                                             and/or device components to become fully
                                                                                                             detached or broken from a mounted system,
                                                                                                             e.g., in interventional stenting procedures,
                                                                                                             the stent, once delivered to the correct and
                                                                                                             intended location, will normally deploy and
                                                                                                             separate from its mounting apparatus.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62928   Failure to service                         Issue associated with the lack of periodic    Service, failure to
                                                                                                             preventive maintenance or performance
                                                                                                             assurance checks.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63158   Failure to shock or properly shock         Issue associated with the inability of device Shock, failure to deliver
                                                                                                             and/or device components to provide a short
                                                                                                             duration of high force or high energy to a
                                                                                                             target location.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62988   Failure to shut off
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63157   Failure to spike                           Issue associated with the distortion in the       Spike, failure to
                                                                                                             form of a pulse waveform of relatively short
                                                                                                             duration superimposed on an otherwise
                                                                                                             regular or desired pulse waveform.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63156   Failure to sterilize                                                                        Sterilization, inadequate|Sterilization failure
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63155   Failure to transmit record                                                                  Record, failure to transmit
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62949   Failure to unfold or unwrap                Issue associated with the comprising             Difficult to unfold or unwrap
                                                                                                             materials' deformation in that a device fails to
                                                                                                             open its wrapping or open/extend to a
                                                                                                             certain fashion or form i.e. balloon or lens.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63154   Failure to unwrap                          Issue associated with problems removing           Unwrap, failure to
                                                                                                             the materials used to construct the cover or
                                                                                                             outer wrapping of the device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62987   Failure to zero                                                                           Zero, failure to
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63152   False alarm                                Issue associated with device providing         Alarm, false
                                                                                                             incorrect alarm warning or alert to user.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63151   False claim in device label                Issue associated with any written, printed, or False claim
                                                                                                             graphic matter that is affixed to a medical
                                                                                                             device or its containers, wrappers; with any
                                                                                                             matter that accompanies a medical device
                                                                                                             including verbal instructions related to
                                                                                                             identification, technical description and use
                                                                                                             of the medical device provided by the device
                                                                                                             manufactures that vary from the standard of
                                                                                                             medical care in a given environment, are
                                                                                                             inaccurate, and lack supporting data. Note
                                                                                                             that labeling can also include DVDs, discs,
                                                                                                             websites provided by device manufacturers.


FDA   C54451   Medical Device Problem Codes FDA CDRH     C63150   False device output                                                                          False output
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63149   False negative result                      Issue associated with the device incorrectly      False-negative test result
                                                                                                             reporting that something has not been
                                                                                                             detected and misleads the operator into not
                                                                                                             taking certain actions when action should be
                                                                                                             taken.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63147   False positive result                      Issue associated with the device incorrectly      False-positive test result
                                                                                                             reporting that something has been detected
                                                                                                             and misleads the operator to take certain
                                                                                                             actions.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63145   False reading from device non-compliance   Issue associated with the non-compliance of       False readings
                                                                                                             the device to meet its specific performance
                                                                                                             characteristics thereby causing a false
                                                                                                             reading.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63144   Filling problem                            Issue associated with the application of a
                                                                                                             material into a physical volume, e.g., tubing
                                                                                                             of an infusion pump or balloon catheter of an
                                                                                                             air pump.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62986   Filtration issue                           Issue associated with the process of passing
                                                                                                             a substance through a porous medium, e.g.,
                                                                                                             a blood clot filter for the removal of
                                                                                                             suspended matter.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63143   Fire                                       Issue associated with destructive burning or
                                                                                                             combustion of inflammable materials as
                                                                                                             manifested by any or all of the following:
                                                                                                             light, flame, heat, smoke.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63142   Fitting problem                            Issue associated with the connection of           Fitting problems
                                                                                                             device and/or device components whereby
                                                                                                             channels, switching systems, and other
                                                                                                             functional units set up to provide means for
                                                                                                             a transfer of liquid, gas, electricity, or
                                                                                                             information do not match or fit.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63141   Flaked                                     Issue associated with the detachment of         Flaking|Flaked material
                                                                                                             small pieces of the coating film of a material.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63140   Flare or flash                             Issue associated with device-related burn
                                                                                                             with an unsteady flame.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63139   Flashpoint threshold met                   Issue associated with approaching certain
                                                                                                             temperatures at which a combustible liquid
                                                                                                             ignites.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63137   Fluid leak                                                                                   Fluid leak(s)
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63135   Fogging                                    Issue associated with the visibility of water
                                                                                                             vapor in the immediate atmosphere in which
                                                                                                             the device is being used.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63134   Folded                                                                                       Fold
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63133   Foreign material present in device         Issue associated with the presence of             Foreign material
                                                                                                             materials, which are not part of the
                                                                                                             documented device specifications and
                                                                                                             requirements.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63132   Fracture                                   Issue associated with any mechanical              Fracture(s) of device/material
                                                                                                             discontinuity in the material; it therefore is
                                                                                                             the collective term for joints, faults, cracks,
                                                                                                             etc.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63130   Free or unrestricted flow                  Issue associated with uncontrolled flow of
                                                                                                             infusion of air, gas or fluids.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63129   Fumes or vapors                             Issue associated with the visibility, odor, or    Fumes/vapors
                                                                                                              toxicity of an ambient vapor or gas which
                                                                                                              affects the operation of the device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63128   Fungus in device environment                Issue associated with the visibility of molds,    Fungus
                                                                                                              mildews, yeasts, and/or mushrooms in the
                                                                                                              immediate environment in which a device is
                                                                                                              being used.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63127   Gas leak                                    Issue associated with the unintended
                                                                                                              leakage of the state of matter in which the
                                                                                                              molecules are practically unrestricted by
                                                                                                              intermolecular forces so that the molecules
                                                                                                              are free to occupy all space within an
                                                                                                              enclosure. In vacuum technology, the word
                                                                                                              gas has been loosely applied to the
                                                                                                              uncondensed gas and vapor within a
                                                                                                              vacuum system.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63316   Gel leak                                                                                      Gel leakage
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63126   Gradient increase                           Issue associated with the increased rate of
                                                                                                              change in temperature, pressure, or other
                                                                                                              variables as a function of distance, time, etc.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63125   Grounding malfunction                       Issue associated with the inability to connect
                                                                                                              conductors of an electronic system for the
                                                                                                              purpose of controlling or impeding ground
                                                                                                              currents and voltages.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C64336   High battery impedance
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63124   High impedance                              Issue associated with a higher than intended Impedance, high
                                                                                                              total opposition that a circuit presents to the
                                                                                                              flow of an alternating current.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62981   High pH                                                                                       pH, high
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63123   High Readings                                                                                 Readings, high
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63122   High test results                                                                             Test results, high
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63121   High threshold                                                                                Threshold, high
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63120   Hole in material                            Issue associated with an opening not              Hole|Hole(s)
                                                                                                              characteristic of the normal material.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63119   Hot oil leak
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63118   Human factors issue                         Issue associated with the interaction and
                                                                                                              interfacing between devices and users in
                                                                                                              terms of users' abilities, expectations, and
                                                                                                              limitations with work environments and
                                                                                                              system design.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63117   Image display error
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62887   Image orientation incorrect                 Issue associated with an incorrect image
                                                                                                              orientation on the device display.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62871   Image resolution poor
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63115   Image reversal
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63114   Impedance issue                             Issue associated with the electrical
                                                                                                              characteristics of the complex resistive and
                                                                                                              reactive attributes of a component in an
                                                                                                              alternating current and direct current
                                                                                                              circuits.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63113   Imprecision
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63112   Improper alarm
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63111   Improper chemical reaction                  Issue associated with inappropriate mixing of
                                                                                                              chemicals.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63108   Improper device output                      Issue associated with the inaccurate
                                                                                                              outcome of a measurement, the value, or
                                                                                                              the data obtained from the device that may
                                                                                                              lead to inappropriate medical action or
                                                                                                              treatment.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63107   Improper device rinsing                                                                       Rinsing, improper
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63110   Improper flow or infusion                   Issue associated with the unsubstantiated
                                                                                                              regulation and delivery of therapy, e.g., air,
                                                                                                              gas, drugs or fluids into a device or a patient
                                                                                                              under positive pressure that is being
                                                                                                              generated by a pump.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63109   Improper gas output                                                                           Gas output, improper
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62862   Improper or incorrect procedure or method   Issue associated with the use of the device       Improper or incorrect method|Method improper/incorrect|Procedure, improper/incorrect
                                                                                                              in terms of non-conforming to that device's
                                                                                                              intended use, specifications, procedure and
                                                                                                              process or service instructions and
                                                                                                              information provided by the device
                                                                                                              manufacturers.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63106   Inability to autofill                                                                         Autofill, unable to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63105   Inability to irrigate                                                                         Irrigate, inability to
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63104   Inaccurate delivery                                                                           Delivery, inaccurate
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63103   Inaccurate dispensing
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63102   Inaccurate flowrate                                                                      Flowrate, inaccurate
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63101   Inaccurate synchronization                  Issue associated with an error due to        Synchronization, inaccurate
                                                                                                              imperfect timing of two operations; this may
                                                                                                              or may not include signal transmission time.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63099   Inadequate device cleaning                  Issue associated with the insufficient          Clean, failure to|Cleaning, inadequate
                                                                                                              removal of unwanted visible soil, foreign
                                                                                                              material or organism deposits on the
                                                                                                              external surfaces, crevices, joints of a device
                                                                                                              by a mechanical and/or manual process
                                                                                                              intended to render the device sterile, safe for
                                                                                                              handling, and/or for further processes to
                                                                                                              decontaminate.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62985   Inadequate filtration process                                                               Filtration process, inadequate
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62870   Inadequate lighting                         Issue associated with an inappropriate level
                                                                                                              of light or illumination in the immediate
                                                                                                              environment in which the device is being
                                                                                                              used or stored.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63096   Inadequate resistance                                                                       Resistance, inadequate
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63098   Inadequate service                          Issue associated with inadequate periodic       Service, inadequate
                                                                                                              preventive maintenance or performance
                                                                                                              assurance checks.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63095   Inadequate storage                          Issue associated with inadequate or             Storage, inadequate|Storage inadequate
                                                                                                              inappropriate storage of the device, not
                                                                                                              otherwise described.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C73117   Inadequate training                         Issue associate with facility not providing
                                                                                                              satisfactory initial and/or periodic user
                                                                                                              training covering operation of the device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63100   Inadequate user interface                   Issue associated with the means by which
                                                                                                              the operator and the equipment
                                                                                                              communicate or interact.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63094   Inappropriate prompts                                                                       Prompts, inappropriate
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63031   Inappropriate reset to default              Issue associated with the inability to
                                                                                                              appropriately perform or generate any
                                                                                                              automated setting if no specific selection has
                                                                                                              made by the users.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63093   Inappropriate shock                         Issue associated with the inappropriate         Shock, inappropriate
                                                                                                              occurrence of a short duration of a high force
                                                                                                              at the initial part of an impact.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63092   Inaudible voice prompts                                                                     Prompts, inaudible voice
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62983   Incompatibility problem                                 Issue associated with any deviations from         Compatibility
                                                                                                                          device documented performance
                                                                                                                          specifications relating to the lack of
                                                                                                                          compatibility between items to properly
                                                                                                                          function together and leading to dysfunction
                                                                                                                          between two or more devices, components,
                                                                                                                          or between the device and the substance
                                                                                                                          (medication, body fluid) it contains or
                                                                                                                          transports. This type excludes
                                                                                                                          disconnection.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63090   Incomplete cooptation                                   Issue associated with the heart valve leaflet
                                                                                                                          not closing properly.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63089   Incomplete instruction                                  Issue associated with the completeness of
                                                                                                                          any written, printed, or graphic matter that is
                                                                                                                          affixed to a medical device or its containers,
                                                                                                                          wrappers; with any matter that accompanies
                                                                                                                          a medical device including verbal
                                                                                                                          instructions related to identification, technical
                                                                                                                          description and use of the medical device
                                                                                                                          provided by the device manufactures.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62940   Incomplete or missing packaging                                                                           Packaging, incomplete/missing
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63318   Incorrect care or use of device                         Issue associated with user's faiilure to          Device, incorrect care/use of
                                                                                                                          process, serive, or operate the device
                                                                                                                          according to the manufacturer's
                                                                                                                          recommendations or recognized best
                                                                                                                          practices.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63084   Incorrect component shipped                             Issue associated with the delivery of an
                                                                                                                          inappropriate device component to a user
                                                                                                                          facility.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63264   Incorrect control settings                              Issue associated with the use of the device       Control settings incorrect
                                                                                                                          in terms of inappropriate and false control
                                                                                                                          setting for the device's specified operation
                                                                                                                          and/or intended use.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63088   Incorrect display                                       Issue associated with device failure and          Display, incorrect
                                                                                                                          malfunction when device does not display
                                                                                                                          adequate results or have proper display.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63206   Incorrect error code
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63087   Incorrect instruction for device use                    Issue associated with inaccuracies in any         Instructions, incorrect
                                                                                                                          written, printed, or graphic matter that is
                                                                                                                          affixed to a medical device or its containers,
                                                                                                                          wrappers; with any matter that accompanies
                                                                                                                          a medical device including verbal
                                                                                                                          instructions related to identification, technical
                                                                                                                          description and use of the medical device
                                                                                                                          provided by the device manufacturers.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63086   Incorrect interpretation of rhythm                                                                    Rhythm, incorrect interpretation of
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63085   Incorrect measurement                                                                                 Measurements, inaccurate
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62848   Incorrect or inadequate result                          Issue associated with a non-conforming end Results incorrect
                                                                                                                          result, data, or test results provided by the
                                                                                                                          device to its performance specifications.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62829   Incorrect or inadequate test results                                                                      Test results, inaccurate
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63082   Incorrect product                                                                                         Product, incorrect
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63081   Incorrect programming calculations                                                                        Programming calculations, incorrect
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63080   Increase in pressure                                                                                      Pressure, increase in
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63079   Increase in suction                                                                                       Aspiration, excessive|Excessive aspiration|Suction, increase in
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63136   Increased fluid or volume                                                                                 Fluid/volume, increased
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63077   Increased pump speed                                                                                      Pump speed, increased
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63078   Increased sensitivity                                                                                     Sensitivity, increased
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63076   Inflation issue                                         Issue associated with the inability of device     Inflation difficulties
                                                                                                                          and/or device components to expand or
                                                                                                                          enlarge with gas or air.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63075   Infusion or flow issue                                  Issue associated with any deviations from
                                                                                                                          device documented performance
                                                                                                                          specifications relating to the regulation and
                                                                                                                          delivery of therapy, e.g., air, gas, drugs or
                                                                                                                          fluids, into a device or patient under positive
                                                                                                                          pressure that is being generated by a pump.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63074   Installation-related problem                            Issue associated with unsatisfactory initial   Installation error
                                                                                                                          installation, configuration, and/or setup of a
                                                                                                                          specific device or technology.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63073                                                           Issue associated with any written, printed, or
                                                                  Instruction for device use is contrary to standard of medical care
                                                                                                                          graphic matter that is affixed to a medical
                                                                                                                          device or its containers, wrappers; with any
                                                                                                                          matter that accompanies a medical device
                                                                                                                          including verbal instructions related to
                                                                                                                          identification, technical description and use
                                                                                                                          of the medical device provided by the device
                                                                                                                          manufactures that depart from the standard
                                                                                                                          of medical care in a given environment.


FDA   C54451   Medical Device Problem Codes FDA CDRH     C63072   Instruction for use issue                               Issue associated with the accuracy and        Instructions, inadequate
                                                                                                                          appropriateness of any written, printed, or
                                                                                                                          graphic matter that is affixed to a medical
                                                                                                                          device or its containers, wrappers; with any
                                                                                                                          matter that accompanies a medical device
                                                                                                                          including verbal instructions related to
                                                                                                                          identification, technical description and use
                                                                                                                          of the medical device provided by the device
                                                                                                                          manufactures.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62912   Instruction missing                                     Issue associated with the absence of any      Missing device instruction
                                                                                                                          written, printed, or graphic matter that is
                                                                                                                          typically affixed to a medical device or its
                                                                                                                          containers, wrappers; or with any matter that
                                                                                                                          typically accompanies a medical device
                                                                                                                          including verbal instructions related to
                                                                                                                          identification, technical description and use
                                                                                                                          of the medical device. Excludes shipping
                                                                                                                          documents which are provided by the device
                                                                                                                          manufacturers.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63071   Insufficient cooling                                    Issue associated with device or device parts Cooling, inadequate
                                                                                                                          being insufficiently cool in device active
                                                                                                                          (working) or/and non-active (non-working)
                                                                                                                          state. The concept does not refer to the
                                                                                                                          problem resulted from ambient temperature.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62823   Insufficient flow or underinfusion                      Issue associated with an underdose of         Underinfusion|Underdelivery
                                                                                                                          intravenous therapy, i.e., drugs or fluids
                                                                                                                          being delivered into a patient under positive
                                                                                                                          pressure generated by a pump.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63070   Insufficient heating                                    Issue associated with device or device parts Heating, inadequate
                                                                                                                          being insufficiently heated in device active
                                                                                                                          (working) or/and non-active (non-working)
                                                                                                                          state. The concept does not refer to the
                                                                                                                          problem resulted from ambient temperature.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63069   Intermittent capture                                    Issue associated with the ineffective and         Capture, intermittent
                                                                                                                          inconsistent depolarization of the heart.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63068   Intermittent continuity                                                                                   Continuity, intermittent
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63067   Intermittent infusion                                                                                     Infusion, intermittent
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63064   Intermittent shock                                    Issue associated with the failure to deliver   Shock, intermittent
                                                                                                                        shock for a limited period of time, following
                                                                                                                        which the item recovers its ability to perform
                                                                                                                        its required function without being subjected
                                                                                                                        to any external corrective action. Note: such
                                                                                                                        as failure is often recurrent.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63061   Invalid sensing                                    Issue associated with the inaccuracy of a      Sensing, invalid
                                                                                                                     device designed to respond to a physical
                                                                                                                     stimulus (as temperature, illumination,
                                                                                                                     motion) to transmit a resulting signal that
                                                                                                                     can not be used for interpretation or
                                                                                                                     measurement.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63019   Item contaminated during manufacturing or shipping Issue associated with the presence of any
                                                                                                                     unexpected foreign substance found on the
                                                                                                                     surface or in the package materials, which
                                                                                                                     may affect optimal performance for its
                                                                                                                     intended use.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63060   Kinked                                                                                            Kink|Kinked material
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63059   Knotted                                                                                           Knot|Knotted material
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63319   Labeling or Instruction for use issue              Issue associated with any written, printed, or
                                                                                                                     graphic matter that is affixed to a medical
                                                                                                                     device or its containers, wrappers, discs,
                                                                                                                     DVDs, websites; with any matter that
                                                                                                                     accompanies a medical device including
                                                                                                                     verbal instructions related to identification,
                                                                                                                     technical description and use of the medical
                                                                                                                     device. Excludes shipping documents
                                                                                                                     which are provided by the device
                                                                                                                     manufacturers.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C72671   Lack of Maintenance Documentation or Guidelines       Issue associated with user facility not
                                                                                                                        receiving adequate service documentation,
                                                                                                                        guidelines, or recommendations to perform
                                                                                                                        preventive and corrective maintenance and
                                                                                                                        performance assurance checks.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63058   Leak                                                  Issue associated with the discontinuity of       Leak(s)
                                                                                                                        flow of gas, air, or fluids from a hole, or void
                                                                                                                        in the wall of an enclosure, capable of
                                                                                                                        passing liquid or gas from one side of the
                                                                                                                        wall to the other under mechanical action of
                                                                                                                        pressure or concentration differential existing
                                                                                                                        across the wall, independent of the quantity
                                                                                                                        of fluid flowing.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63057   Light interference
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63056   Looping
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63055   Loose connection                                                                                        Connection(s), loose
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63054   Loss of augmentation                                                                                    Augmentation, loss of
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63194   Loss of or failure to bond                            Issue associated with a failure mode              Bond, failure to
                                                                                                                        characterized by inability to bond or loss of
                                                                                                                        bond either between the anchor and
                                                                                                                        adhesive or between the adhesive and the
                                                                                                                        base material.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63053   Loss of osseointegration                                                                                Osseointegration, loss of
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63052   Loss of power                                         Issue associated with the failure of primary      Power, loss of
                                                                                                                        power supplied by the facility.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63051   Loss of resistance                                                                                      Resistance, loss of
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63050   Loss of threshold                                     Issue associated with the loss of the             Threshold, loss of
                                                                                                                        minimum amount of energy, voltage, or
                                                                                                                        current needed to consistently stimulate the
                                                                                                                        heart muscle.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63049   Low audible alarm                                                                                       Alarm, low audible
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63048   Low battery                                                                                             Battery, low
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C64335   Low battery impedance
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63047   Low impedance                                         Issue associated with a lower than intended       Impedance, low
                                                                                                                        total opposition that a circuit presents to the
                                                                                                                        flow of an alternating current.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63046   Low readings                                                                                            Readings, low
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63045   Low test results                                                                                        Test results, low
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63044   Low threshold                                                                                           Threshold, low
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62978                                                        Issue associated with the non-compliance or
                                                                  Maintenance does not comply to manufacturers recommendations                                            Maintenance not to manufacturers recommendations
                                                                                                                       non-performance to manufacturer
                                                                                                                       specifications relating to device routine
                                                                                                                       maintenance, i.e., periodic inspection, failure
                                                                                                                       detection, repair, and care of the device to
                                                                                                                       sustain or restore acceptable operating
                                                                                                                       conditions.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63043   Malposition of device                                Issue associated with device rotation in the       Malposition
                                                                                                                       pocket or is riding to high or low.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63041                                                        Issue associated with any deviations from
                                                                  Manufacturing or shipping issue associated with device
                                                                                                                       device documented performance
                                                                                                                       specifications relating to non-conformity
                                                                                                                       during manufacture to the design of an item
                                                                                                                       or to specified manufacturing processes.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63248   Material deformation                                  Issue associated with an undesired material
                                                                                                                        change in shape or property caused by
                                                                                                                        forces of compression, shear, tension, or
                                                                                                                        torsion in the materials used for device
                                                                                                                        construction.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63224   Material discolored                                   Issue associated with an undesired streak,    Discolored
                                                                                                                        pattern, and/or a noticeable change in color
                                                                                                                        from the rest of the materials used in device
                                                                                                                        construction.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63222   Material disintegration                               Issue associated with material breakage into Disintegrate
                                                                                                                        components or fragments after exposure to
                                                                                                                        a given fluid and/or environment; the
                                                                                                                        reduction of massive material to powder.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C72894   Material Distortion                                   Issue associated with undesired physical
                                                                                                                        appearance of device material resulting from
                                                                                                                        excessive stress or impact.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63208   Material erosion                                      Issue associated with a progressive loss of a Erosion
                                                                                                                        material from a solid surface due to a
                                                                                                                        mechanical interaction between that surface
                                                                                                                        and a fluid, a multi-component fluid, or solid
                                                                                                                        particles carried with the fluid.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62969   Material fragmentation                                Issue associated with the breaking of a        Fragmentation
                                                                                                                        material in such a way the bulk of the
                                                                                                                        material is of a convenient size for handling.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63131   Material frayed                                       Issue associated with the comprising              Frayed
                                                                                                                        materials having damaged edges.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62968   Material integrity issue                              Issue associated with any deviations from
                                                                                                                        device documented performance
                                                                                                                        specifications relating to the limited durability
                                                                                                                        of all material used to construct the device.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63063   Material invagination                                                                             Invagination
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62895   Material opacification                                Issue associated with an undesirable        Opacification|Opaque
                                                                                                                        opaqueness or cloudiness.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62967   Material perforation                                  Issue associated with an undesired material Perforation
                                                                                                                        damage characterized by closely spaced
                                                                                                                        punched or drilled holes.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C72891   Material Protrusion                           Issue associated with undesired physical
                                                                                                                appearance of device material, specifically
                                                                                                                when material extends beyond or above the
                                                                                                                device surface.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62966   Material puncture                             Issue associated with the comprising           Puncture
                                                                                                                material(s) being penetrated, pierced or
                                                                                                                punctured, especially with a sharp or pointed
                                                                                                                object.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62847   Material rigid or stiff                                                                      Rigid or stiff|Rigid
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62965   Material rupture                              Issue associated with the breaking or tearing Rupture
                                                                                                                apart of a material.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62964   Material separation                           Issue associated with an undesired             Separation|Separates
                                                                                                                disassociation or breaking apart of materials
                                                                                                                used in device construction.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C64340   Material torqued                              Issue associated with a movement of forces Torqued
                                                                                                                that produces or tends to produce rotation or
                                                                                                                torsion of a material
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62962   Material twisted                                                                             Twisting
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63040   Measurement system incompatibility            Issue associated with the incompatibility of
                                                                                                                the measurement systems between and/or
                                                                                                                within device systems that are inherent to
                                                                                                                the individual device thereby leading to
                                                                                                                miscalculated or mismatched
                                                                                                                measurements from those devices, e.g.,
                                                                                                                international metric system versus U.S.
                                                                                                                measurement system.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62961   Mechanical issue                              Issue associated with any deviations from      Mechanical failure
                                                                                                                device documented performance
                                                                                                                specifications relating to mechanical defects,
                                                                                                                including moving parts or subassemblies,
                                                                                                                etc.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63039   Mechanical jam                                Issue associated with a clogging action
                                                                                                                which can produce a chain stop of the
                                                                                                                device and/or device components' overall
                                                                                                                processes.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62960   Mechanics altered                             Issue associated with device mechanical
                                                                                                                functioning of machinery, moving parts or
                                                                                                                tools of the device being changed or
                                                                                                                modified.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C72887   Medical Gas Supply Problem                    Issue associated with the facility-supplied
                                                                                                                medical gases such as medical air, oxygen,
                                                                                                                nitrous oxide, and nitrogen.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62908   Melted                                        Issue associated with the evidence of          Material molten|Melts
                                                                                                                material softening, resulting in a
                                                                                                                nonreversible change.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62918   Metal shedding debris                                                                        Debris, metal shedding
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62917   Migration of device or device component       Issue associated with an undesired             Migration
                                                                                                                movement of device and/or device
                                                                                                                components, related to its movement away
                                                                                                                from or dislodging from a source.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62959   Misapplied device                                                                            Misapplication
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62958   Misassembled by users                         Issue associated with the use of the device Misassembly
                                                                                                                characterized by users' incorrect assembly of
                                                                                                                device components, parts or constituents.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62915   Misconnection                                 Issue associated with the connection of           Improper connection
                                                                                                                device and/or device components being
                                                                                                                improper or not in accordance with device
                                                                                                                specification, requirements and intended
                                                                                                                uses.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62914   Misfire                                       Issue associated with device and/or device
                                                                                                                components' inability to create a blasting
                                                                                                                charge to explode when expected.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62913   Misfocusing
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62911   Missing device label                                                                            Labeling, missing
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62901   Missing device markings                                                                         Markings, none|No markings on device
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62910   Moisture damage                               Issue associated with damage inflicted upon
                                                                                                                device surfaces from water vapor or water in
                                                                                                                the immediate environment in which the
                                                                                                                device is being used.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62909   Moisture or humidity problem                  Issue associated with an unsatisfactory
                                                                                                                humidity level in the environment in which
                                                                                                                the device is being used or stored.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62907   Mushroomed
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62906   Naturally worn                                Issue associated with material damage to a
                                                                                                                surface, usually involving progressive loss or
                                                                                                                displacement of material, due to relative
                                                                                                                motion between that surface and a
                                                                                                                contacting substance or substances.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C64343   No code available
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62900   No device output                              Issue associated with no measurement              Output, none
                                                                                                                outcome, value, or data obtained from the
                                                                                                                device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62904   No display or display failure                 Issue associated with the absence of visual       Display, failure to
                                                                                                                indicator.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62903   No fail-safe mechanism
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62902   No flow                                       Issue associated with no intravenous
                                                                                                                therapy, i.e., drugs or fluids being delivered
                                                                                                                into a patient, even in the presence of
                                                                                                                positive pressure generated by a pump.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C53269   No Information Available                                                                        No Answer Provided
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C64243   No Pressure
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62899   No voice prompts                                                                                Prompts, no voice
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62898   Nonstandard device or device component        Issue associated with a material that does
                                                                                                                not meet the specifications or requirements
                                                                                                                for which it was manufactured, and has not
                                                                                                                been subjected to use or processing other
                                                                                                                than that required for its initial manufacture.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C48660   Not Applicable
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63310   Not audible alarm                                                                           Alarm, not audible
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62897   Obstruction within device                                                                   Obstruction
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62896   Occlusion within device                       Issue associated with obstruction, closure or Plugged|Occlusion
                                                                                                                blockage of device opening, pipe, tube or
                                                                                                                another narrow comprising part.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62894   Operating system becomes non-functional       Issue that occur as a result of malfunction of
                                                                                                                the computer operating system (e.g
                                                                                                                Microsoft Vista) vs. an application software
                                                                                                                issue.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62893   Operating system version or upgrade problem   Issue associated with replacing an older
                                                                                                                operation system to an up-to-date operation
                                                                                                                system.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62892   Operator calculation or calibration error     Issue associated with the use of the device
                                                                                                                in terms of erroneous calculation and/or
                                                                                                                miscalibration by users and/or operators of
                                                                                                                the device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62891   Optical decentration                          Issue associated with being off-center of      Lens, decentration of
                                                                                                                optical lenses.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62890   Optical discoloration                         Issue associated with an optical streak or
                                                                                                                other pattern on the signal surface that
                                                                                                                causes a noticeable change of color from the
                                                                                                                rest of the pultruded surface.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62889   Optical distortion                                    Issue associated with an optical defect in an
                                                                                                                        image-forming system whereby the image is
                                                                                                                        not the shape of an ideal image of the
                                                                                                                        object.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62953   Optical issue                                         Issue associated with any deviations from
                                                                                                                        device documented performance
                                                                                                                        specifications relating to the luminous
                                                                                                                        transmittance of visible light through the
                                                                                                                        central pupillary (optical) area; or in short
                                                                                                                        relating to light and vision characteristics of
                                                                                                                        devices.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62888   Optical obstruction                                   Issue associated with the blocking of optical
                                                                                                                        devices, e.g., visual pathways.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62886   Osseointegration issue                                Issue associated with a mechanical
                                                                                                                        implication that a contact is established
                                                                                                                        without interposition of non-bone tissue
                                                                                                                        between normal remodeled bone and an
                                                                                                                        implant entailing a sustained transfer and
                                                                                                                        distribution of load from the implant to and
                                                                                                                        within the bone tissue.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62944   Out-of-box failure
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62943   Output above specifications
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62942   Output below specifications
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63002   Output energy incorrect
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62941   Output issue                                          Issue associated with any deviation from
                                                                                                                        device documented performance
                                                                                                                        specifications relating to the end result, data,
                                                                                                                        or test results provided by the device.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C72890   Overcorrection                                        Issue associated with an adjustment that
                                                                                                                        surpasses a set criterion.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62884   Overfill
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62883   Overheating of device or device component             Issue associated with the excessive heating        Overheat
                                                                                                                        or high temperature beyond the tolerance
                                                                                                                        level such that the properties and structure
                                                                                                                        undergo severe modification.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62881   Oversensing
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62880   Pacer found in back-up mode
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63298   Pacing asynchronously                                 Issue associated with a pacing transmission
                                                                                                                        process such that between any two
                                                                                                                        significant instants in the same group, there
                                                                                                                        is always an integral number of unit
                                                                                                                        intervals. Between two significant instants
                                                                                                                        located in different groups, there are not
                                                                                                                        always an integral number of unit intervals.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63097   Pacing inadequately                                   Issue associated with an inadequate voltage
                                                                                                                        generated by a ground current between two
                                                                                                                        points on the surface of the ground at a
                                                                                                                        distance apart corresponding to the
                                                                                                                        conventional length of an ordinary pace.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63066   Pacing intermittently                                 Issue associated with the failure of pacing
                                                                                                                        device for a limited period of time, following
                                                                                                                        which the item recovers its ability to perform
                                                                                                                        its required function without being subjected
                                                                                                                        to any external corrective action. Note: such
                                                                                                                        as failure is often recurrent.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62939   Packaging issue                                     Issue associated with the materials used to
                                                                                                                      construct the cover or outer wrapping of the
                                                                                                                      device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63083   Parameter calculation error due to software problem                                                      Parameter calculations, incorrect
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62879   Particulates                                        Substances that consist of separate
                                                                                                                      partiicles that are introduced by the device
                                                                                                                      during use.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62919   Patient-device incompatibility                      Issue associated with the incompatibility of
                                                                                                                      the device and patient while operating in the
                                                                                                                      same use environment, thereby leading to a
                                                                                                                      dysfunction between the device and the
                                                                                                                      patient.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62878   Peeled                                              Issue associated with stresses of sufficient         Peeling|Peeled device material
                                                                                                                      magnitude to exceed the strength of
                                                                                                                      adhesion between the device material and
                                                                                                                      its coating, i.e., insulation pulling away from
                                                                                                                      a wire.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62876   Perivalvular leak                                   Issue associated with the escape of blood            Leak(s), perivalvular|Paravalvular leak|Paravalvular leak(s)
                                                                                                                      around a heart valve, particularly around its
                                                                                                                      leaflets.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62937   Physical property issue                             Issue associated with any deviations from            Device physical property issue
                                                                                                                      specifications relating to device physical
                                                                                                                      properties in terms of material integrity,
                                                                                                                      mechanical, manufacturing/shipping,
                                                                                                                      communication/transmission, optical,
                                                                                                                      temperature, chemical, and electronic
                                                                                                                      issues.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62875   Physical resistance                                                                                      Resistance, physical
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62874   Pitted                                              Issue associated with the corrosion of a             Pitting
                                                                                                                      material's surface, confined to a point or
                                                                                                                      small area that takes the form of cavities.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62873   Plunge
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62872   Pocket stimulation                                  Issue associated with a pocket of skin in
                                                                                                                      which the pulse generator is housed.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62935   Polarity switch                                     Issue associated with the output signal or           Device polarity switch
                                                                                                                      power is reversed by physical or electrical
                                                                                                                      means, e.g., in a multiple cell, series-
                                                                                                                      connected battery this may be called cell
                                                                                                                      reversal. Here, a cell is discharged
                                                                                                                      completely and recharged with a reversed
                                                                                                                      polarity by the continued discharge of the
                                                                                                                      remaining cells.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62869   Poor quality image                                  Issue associated with an image or any visual         Monitor, image quality poor
                                                                                                                      representation displayed by the device with
                                                                                                                      non- distinctive characteristics.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62916   Power calculation error due to software problem                                                          Power, miscalculation of
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62868   Power conditioning issue                              Issue associated with inadequate power
                                                                                                                        conditioning such as the presence of
                                                                                                                        fluctuation, surges, spikes, dropouts, noice
                                                                                                                        and other such undesirable transients.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C63025   Power source issue
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62867   Pre or post-pumping problem                                                                         Pre/post-pumping problems
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62866   Precipitate in device or device ingredient            Issue associated with the separation of solid Precipitate
                                                                                                                        particles from a liquid as the result of a
                                                                                                                        chemical or physical change.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62863   Premature deployment                                  Issue associated with an early and            Premature system activation
                                                                                                                        unexpected deployment of the device and/or
                                                                                                                        device components from the system.

FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62864   Premature discharge of battery                                                                           Battery, premature discharge of
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63315   Premature elective replacement indicator                                                                 Premature ERI
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63320   Premature end-of-life indicator                                                                          Premature EOL
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62865   Premature indicator activation
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62934   Pressure issue                                        Issue associated with the application of a
                                                                                                                        force to a surface area during device
                                                                                                                        preparation or use.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62933   Pre-use inspection not performed                        Issue associated with the use of the device
                                                                                                                          whereby a detailed examination or thorough
                                                                                                                          visual and functional checking prior to use is
                                                                                                                          absent.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C67507   Problem with software installation                      Issue associated with installing the device
                                                                                                                          software in a manner that allows full
                                                                                                                          functioning of the device. Source of
                                                                                                                          installation could be manufacturer or user.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62956   Product mislabeled                                      Issue associated with the misbranding or      Mislabeled
                                                                                                                          false labeling of an operating system,
                                                                                                                          product, or device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62948   Product quality issue                                   Issue associated with an inherited device     Device or device component quality issue|Quality, unsatisfactory or poor
                                                                                                                          and/or device component characteristic that
                                                                                                                          may not be satisfactory as specified.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62839   Programming issue                                       Issue associated with the written program
                                                                                                                          code the application software used to satisfy
                                                                                                                          a stated need or objective for functioning of
                                                                                                                          the deivce. These do not include issues
                                                                                                                          associated with the operating system (e.g.
                                                                                                                          MS Vista).
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62861   Prompts will not clear
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62932   Protective measure issue                                Issue associated with any deviations from
                                                                                                                          device documented performance
                                                                                                                          specifications relating to the implemented
                                                                                                                          and inherited design features specific to
                                                                                                                          devices used for reducing risks to, or
                                                                                                                          maintaining risks within, specified levels of
                                                                                                                          the device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62860   Pumping issue                                           Issue associated with the inability to achieve
                                                                                                                          positive pressure from the device and/or
                                                                                                                          device components in order to deliver
                                                                                                                          intravenous therapy such i.e. drugs or fluids
                                                                                                                          to patients.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62859   Pumping stopped                                                                                           Pumping, stopped
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62858   Radiation delivered to incorrect body area
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62857   Radiation leak                                                                                         Leak, radiation
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C72892   Radiation overexposure                                  Issue associated with excessive radiation
                                                                                                                          emitted from radiological or diagnostic
                                                                                                                          device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C72893   Radiation Underexposure                                 Issue associated with too little radiation
                                                                                                                          emitted from radiological or diagnostic
                                                                                                                          devices. Results in insufficient production of
                                                                                                                          normal image contrast.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62856   Radio signal problem                                    Issue associated with the wireless             Radio signal problems
                                                                                                                          transmission signal in the lowest range of
                                                                                                                          the electromagnetic spectrum.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62855   Radiofrequency interference (RFI)                       Issue associated with the degradation of the RFI
                                                                                                                          reception of a wanted signal caused by RF
                                                                                                                          disturbance.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62854   Reflux within device                                    Issue associated with a backward or return Reflux
                                                                                                                          flow.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62853   Rejection
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62852   Reset issue                                             Issue associated with setting a variable,
                                                                                                                          register, or other storage location back to a
                                                                                                                          prescribed state.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62851   Resetting of shock counters                             Issue associated with a device such as a        Shock counters, resetting of
                                                                                                                          register or storage location used to represent
                                                                                                                          the number of occurrences of an event, such
                                                                                                                          as shock delivery, resets itself without any
                                                                                                                          instruction to do so; an instrument for storing
                                                                                                                          integers, permitting these integers to be
                                                                                                                          increased or decreased sequentially by unity
                                                                                                                          or by an arbitrary integer, and capable of
                                                                                                                          being reset to zero or to an arbitrary integer.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62850   Residue after decontamination                           Issue associated with the decontamination         Residue
                                                                                                                          process not adequately removing unwanted
                                                                                                                          visible soil, foreign material, or organism
                                                                                                                          deposits.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62849   Restricted flowrate                                                                                       Flowrate, restricted
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62929   Retraction problem                                      Issue associated with drawing back the            Retract, failure to
                                                                                                                          device and/or device component to an
                                                                                                                          intended location.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C73500   Retrograde Flow
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62846   Scratched material                                      Issue associated with an undesirable          Scratched
                                                                                                                          shallow cut or narrow groove in the surface
                                                                                                                          of the materials used in device construction.

FDA   C54451   Medical Device Problem Codes FDA CDRH     C62845   Sediment, precipitate or deposit in device or device ingredient
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62844   Self-activation or keying                              Issue associated with the unintended               Self-activation/keying
                                                                                                                         activation of device, or device having been
                                                                                                                         unexpectedly turned on during use.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C63065   Sensing intermittently
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62926   Shelf life exceeded                                    Issue associated with the using a device
                                                                                                                         after the marked or known shelf life.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62842   Shielding failure                                      Issue associated with device inability to act
                                                                                                                         as a barrier for absorption of radiation energy
                                                                                                                         in X-rays, gamma rays, etc.
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62925   Shipping damage or problem
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62841   Short fill
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62947   Size incorrect for patient                                                                                Size, incorrect
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C62840   Slippage of device or device component                                                                    Slippage
FDA   C54451   Medical Device Problem   Codes FDA CDRH   C63003   Smoking                                                Issue associated with a cloud of vapor or gas      Smoke
                                                                                                                         generated from the device, generally
                                                                                                                         associated after a fire or a burn.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62838   Solder joint failure
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62837   Spark                                                  Issue associated with a high voltage
                                                                                                                         capacitor discharge characterized by a
                                                                                                                         visible electrical glowing.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62963   Split                                                  Issue associated with an undesired tearing         Material split|Splitting
                                                                                                                         of the material membrane that may be due
                                                                                                                         to exceeding the tensile stress limits
                                                                                                                         belonging to the materials used in device
                                                                                                                         construction.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62836   Sticking
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62835   Stretched                                              Issue associated with an increase or               Material stretched
                                                                                                                         elongation in a materials' dimension.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62834   Strikethrough
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62923   Structural problem                                     Issue associated with the basic physical           Structural failure
                                                                                                                         construction or physical make up of the
                                                                                                                         device.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62833   Suction issue                                          Issue associated with suction equipment,           Suction failure
                                                                                                                         which may be a manual, electrical, vacuum
                                                                                                                         or pressure source operated to evacuate and
                                                                                                                         remove undesired substances (air, gas,
                                                                                                                         fluid, or particulates via tubing and collection
                                                                                                                         bag.
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62831   Tear, rip or hole in device packaging                                                                     Packaging, tears, rips, holes in
FDA   C54451   Medical Device Problem Codes FDA CDRH     C62830   Telemetry discrepancy                                  Issue associated with variability of the
                                                                                                                         transmission of signals, which can be
                                                                                                                         characterized as telemetry channel coding, a
                                                                                                                         method of processing data sent from a
                                                                                                                         source to a destination so that distinct
                                                                                                                         messages are created which are easily
                                                                                                                         distinguishable from one another.
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62922   Temperature issue                               Issue associated any deviations from device
                                                                                                                      documented performance specifications
                                                                                                                      relating to the thermal state of the device
                                                                                                                      operations as measured on a defined scale.

FDA   C54451   Medical Device Problem Codes FDA CDRH         C62828   Therapeutic or diagnostic output failure        Issue associated with the failure of the
                                                                                                                      device to deliver any end results relating to
                                                                                                                      treatment or identification of a disease.
FDA   C54451   Medical Device Problem Codes FDA CDRH         C63138   Tidal volume fluctuations                       Issue associated with the amount of gas that
                                                                                                                      is inspired and expired during one
                                                                                                                      respiratory cycle.
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62921   Tipover                                                                                         Device tipover
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62832   Torn material                                   Issue associated with comprising material(s)
                                                                                                                      being pulled apart or into pieces by force,
                                                                                                                      wrenching, or laceration.
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62827   Ultrafiltration                                 Issue associated with the transfer of fluid
                                                                                                                      between the blood and dialysate through the
                                                                                                                      dialysis membrane due to a pressure
                                                                                                                      gradient (transmembrane pressure) existing
                                                                                                                      between the blood and dialysate
                                                                                                                      compartments.
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62826   Unable to obtain readings                                                                       Readings, unable to obtain
FDA   C54451   Medical Device Problem Codes FDA CDRH         C63259   Unauthorized access to computer system          Issue associated with an access that was
                                                                                                                      not permitted to the computer system that
                                                                                                                      may lead to modification of program,
                                                                                                                      corruption of data, or and break in network
                                                                                                                      security. This concept is closely associated
                                                                                                                      with computer integrity which is the degree
                                                                                                                      to which a system or component prevents
                                                                                                                      unauthorized access to, or modification of,
                                                                                                                      computer programs or data.

FDA   C54451   Medical Device Problem Codes FDA CDRH         C62825   Uncoiled
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62822   Undersensing
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62821   Unexpected therapeutic results                  Issue associated with the use of a medical      Therapeutic results, unexpected
                                                                                                                      device for therapeutic purposes.
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62820   Unintended arm motion                                                                        Arm motion, unintended
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62819   Unintended collision                            Issue associated with an unwanted condition Collision, unintended
                                                                                                                      that results from concurrent transmission on
                                                                                                                      the physical medium.
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C62817   Unintended ejection of film cartridge                                                        Film cartridge ejection, unintended
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C62818   Unintended energization                                                                      Device energization, unintended|Unintended device energization
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C62816   Unintended head motion                                                                       Head motion, unintended
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C62815   Unintended magnet quench                                                                     Magnet quench, unintended
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C62814   Unintended movement                             Issue associated with an undesired
                                                                                                                      movement of device, which may be related
                                                                                                                      to device malfunction, misdiagnosis, or
                                                                                                                      mistreatment.
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62813   Unintended system motion                        Issue associated with any motion of the      System motion, unintended
                                                                                                                      system or components that was not initiated
                                                                                                                      by the user.
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C62812   Unit inactivated
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C17998   Unknown                                                                                         Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known)
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C62811   Unraveled material
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C62810   Unsealed device packaging                                                                       Packaging, unsealed
FDA   C54451   Medical Device Problem   Codes FDA CDRH       C62809   Unstable                                        Issue associated with the connection of
                                                                                                                      device and/or device components not
                                                                                                                      possessing stability, or is unbounded.
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62807   Ventilation issue in device environment
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62806   Vibration                                       Issue associated with an oscillation wherein
                                                                                                                      the quantity is a parameter that defines the
                                                                                                                      motion of a mechanical system.

FDA   C54451   Medical Device Problem Codes FDA CDRH         C62805   Volume accuracy issue                                                                           Volume accuracy
FDA   C54451   Medical Device Problem Codes FDA CDRH         C62804   Wrinkled                                                                                        Wrinkled material|Wrinkling
FDA   C54585   Occupation ICSR Terminology                   C51959   Attorney
FDA   C54585   Occupation ICSR Terminology                   C51804   Audiologist
FDA   C54585   Occupation ICSR Terminology                   C51960   Biomedical Engineer
FDA   C54585   Occupation ICSR Terminology                   C53428   Dental Assistant
FDA   C54585   Occupation ICSR Terminology                   C53293   Dental Hygienist
FDA   C54585   Occupation ICSR Terminology                   C52654   Dentist
FDA   C54585   Occupation ICSR Terminology                   C28248   Dietician
FDA   C54585   Occupation ICSR Terminology                   C53417   Emergency Medical Technician
FDA   C54585   Occupation ICSR Terminology                   C53287   Health Care Professional
FDA   C54585   Occupation ICSR Terminology                   C53429   Home Health Aid
FDA   C54585   Occupation ICSR Terminology                   C53433   Hospital Service Technician
FDA   C54585   Occupation ICSR Terminology                   C50913   Invalid Data
FDA   C54585   Occupation ICSR Terminology                   C53430   Medical Assistant
FDA   C54585   Occupation ICSR Terminology                   C53442   Medical Equipment Company Technician or Representative
FDA   C54585   Occupation ICSR Terminology                   C53418   Medical Technologist
FDA   C54585   Occupation ICSR Terminology                   C53269   No Information Available                                                                        No Answer Provided
FDA   C54585   Occupation ICSR Terminology                   C48660   Not Applicable
FDA   C54585   Occupation ICSR Terminology                   C53419   Nuclear Medicine Technologist
FDA   C54585   Occupation ICSR Terminology                   C20821   Nurse
FDA   C54585   Occupation ICSR Terminology                   C53431   Nursing Assistant
FDA   C54585   Occupation ICSR Terminology                   C25193   Occupation
FDA   C54585   Occupation ICSR Terminology                   C28174   Occupational Therapist
FDA   C54585   Occupation ICSR Terminology                   C17649   Other                                                                                           Other
FDA   C54585   Occupation ICSR Terminology                   C53427   Other Caregiver
FDA   C54585   Occupation ICSR Terminology                   C53289   Other Health Care Professional
FDA   C54585   Occupation ICSR Terminology                   C53420   Paramedic
FDA   C54585   Occupation ICSR Terminology                   C51840   Pharmacist
FDA   C54585   Occupation ICSR Terminology                   C53421   Phlebotomist
FDA   C54585   Occupation ICSR Terminology                   C53422   Physical Therapist
FDA   C54585   Occupation ICSR Terminology                   C25741   Physician
FDA   C54585   Occupation ICSR Terminology                   C53423   Physician Assistant
FDA   C54585   Occupation ICSR Terminology                   C53446   Physicist
FDA   C54585   Occupation ICSR Terminology                   C53424   Radiologic Technologist
FDA   C54585   Occupation ICSR Terminology                   C53425   Respiratory Therapist
FDA   C54585   Occupation ICSR Terminology                   C53448   Risk Manager
FDA   C54585   Occupation ICSR Terminology                   C53441   Service and Testing Personnel
FDA   C54585   Occupation ICSR Terminology                   C53273   Service Personnel
FDA   C54585   Occupation ICSR Terminology                   C28247   Speech Therapist
FDA   C54585   Occupation ICSR Terminology                   C17998   Unknown                                                                                         Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known)
FDA   C54584   Operator of Medical Device ICSR Terminology   C51804   Audiologist
FDA   C54584   Operator of Medical Device ICSR Terminology   C51960   Biomedical Engineer
FDA   C54584   Operator of Medical Device ICSR Terminology   C53428   Dental Assistant
FDA   C54584   Operator of Medical Device ICSR Terminology   C53293   Dental Hygienist
FDA   C54584   Operator of Medical Device ICSR Terminology   C52654   Dentist
FDA   C54584   Operator of Medical Device ICSR Terminology   C53274   Device Unattended
FDA   C54584   Operator of Medical Device ICSR Terminology   C28248   Dietician
FDA   C54584   Operator of Medical Device ICSR Terminology   C53417   Emergency Medical Technician
FDA   C54584   Operator of Medical Device ICSR Terminology   C53287   Health Care Professional
FDA   C54584   Operator of Medical Device ICSR Terminology   C53429   Home Health Aid
FDA   C54584   Operator of Medical Device ICSR Terminology   C53433   Hospital Service Technician
FDA   C54584   Operator of Medical Device ICSR Terminology   C50913   Invalid Data
FDA   C54584   Operator of Medical Device ICSR Terminology   C53430   Medical Assistant
FDA   C54584   Operator of Medical Device ICSR Terminology   C53442   Medical Equipment Company Technician or Representative
FDA   C54584   Operator of Medical Device ICSR Terminology   C53418   Medical Technologist
FDA   C54584   Operator of Medical Device ICSR Terminology   C53269   No Information Available                                                                        No Answer Provided
FDA   C54584   Operator of Medical Device ICSR Terminology   C48660   Not Applicable
FDA   C54584   Operator of Medical Device ICSR Terminology   C53419   Nuclear Medicine Technologist
FDA   C54584   Operator of Medical Device ICSR Terminology   C20821   Nurse
FDA   C54584   Operator of Medical Device ICSR Terminology   C53431   Nursing Assistant
FDA   C54584   Operator of Medical Device ICSR Terminology   C28174   Occupational Therapist
FDA   C54584   Operator of Medical Device ICSR Terminology   C53272   Operator of Medical Device
FDA   C54584   Operator of Medical Device ICSR Terminology   C17649   Other                                                                                           Other
FDA   C54584   Operator of Medical Device ICSR Terminology   C53427   Other Caregiver
FDA   C54584   Operator of Medical Device ICSR Terminology   C53289   Other Health Care Professional
FDA   C54584   Operator of Medical Device ICSR Terminology   C53420   Paramedic
FDA   C54584   Operator of Medical Device ICSR Terminology   C16960   Patient                                                                                          Lay User/Patient
FDA   C54584   Operator of Medical Device ICSR Terminology   C53432   Patient Family Member Or Friend
FDA   C54584   Operator of Medical Device ICSR Terminology   C51840   Pharmacist
FDA   C54584   Operator of Medical Device ICSR Terminology   C53421   Phlebotomist
FDA   C54584   Operator of Medical Device ICSR Terminology   C53422   Physical Therapist
FDA   C54584   Operator of Medical Device ICSR Terminology   C25741   Physician
FDA   C54584   Operator of Medical Device ICSR Terminology   C53423   Physician Assistant
FDA   C54584   Operator of Medical Device ICSR Terminology   C53446   Physicist
FDA   C54584   Operator of Medical Device ICSR Terminology   C53424   Radiologic Technologist
FDA   C54584   Operator of Medical Device ICSR Terminology   C53425   Respiratory Therapist
FDA   C54584   Operator of Medical Device ICSR Terminology   C53448   Risk Manager
FDA   C54584   Operator of Medical Device ICSR Terminology   C53441   Service and Testing Personnel
FDA   C54584   Operator of Medical Device ICSR Terminology   C53273   Service Personnel
FDA   C54584   Operator of Medical Device ICSR Terminology   C28247   Speech Therapist
FDA   C54584   Operator of Medical Device ICSR Terminology   C17998   Unknown                                                                                          Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known)
FDA   C54450   Patient Problem Codes FDA CDRH                C34331   Abdominal Cramps                                                                                 Cramps, abdominal
FDA   C54450   Patient Problem Codes FDA CDRH                C35221   Abortion
FDA   C54450   Patient Problem Codes FDA CDRH                C50500   Abortion, Complete                          All products of conception are expelled and
                                                                                                                  identified.
FDA   C54450   Patient Problem Codes FDA CDRH                C50608   Abortion, Incomplete                        The uterus is not entirely emptied of its
                                                                                                                  contents.
FDA   C54450   Patient Problem Codes FDA CDRH                C50613   Abortion, Induced                           Abortion brought on intentionally.                   Abortion, Artificial|Induced abortion|Artificial abortion
FDA   C54450   Patient Problem Codes FDA CDRH                C50652   Abortion, Missed                            Retention in uterus of an abortus that has
                                                                                                                  been dead at least 4 weeks.
FDA   C54450   Patient Problem Codes FDA CDRH                C34338   Abortion, Therapeutic
FDA   C54450   Patient Problem Codes FDA CDRH                C50449   Abrasion                                    Abraded wound; excoriation or
                                                                                                                  circumscribed removal of the superficial
                                                                                                                  layers of the skin or mucous membrane.
FDA   C54450   Patient Problem Codes FDA CDRH                C26686   Abscess
FDA   C54450   Patient Problem Codes FDA CDRH                C50451   Achalasia                                   Failure of the smooth muscle fibers of the
                                                                                                                  gastrointestinal tract to relax at any one point
                                                                                                                  of junction of one part with another.
FDA   C54450   Patient Problem   Codes FDA CDRH              C50453   Acoustic Trauma
FDA   C54450   Patient Problem   Codes FDA CDRH              C54685   Adhesion(s)
FDA   C54450   Patient Problem   Codes FDA CDRH              C3353    Adult Respiratory Distress Syndrome                                                              ARDS|Adult respiratory distress syndrome, ARDS
FDA   C54450   Patient Problem   Codes FDA CDRH              C2851    AIDS, Acquired Immunodeficiency Syndrome                                                         Acquired immunodeficiency syndrome, AIDS
FDA   C54450   Patient Problem   Codes FDA CDRH              C50455   Air Embolism                                The presence of bubbles of gas in the
                                                                                                                  vascular system; occurrence is related to the
                                                                                                                  entry of air into the venous circulation
                                                                                                                  following trauma or surgery.
FDA   C54450   Patient Problem   Codes FDA CDRH              C50456   Airway Obstruction
FDA   C54450   Patient Problem   Codes FDA CDRH              C7941    Alteration in Body Temperature
FDA   C54450   Patient Problem   Codes FDA CDRH              C50458   Ambulation Difficulties                                                                          Difficulties, ambulation
FDA   C54450   Patient Problem   Codes FDA CDRH              C50459   Amnionitis                                  Inflammation of the amnion.
FDA   C54450   Patient Problem   Codes FDA CDRH              C15179   Amputation
FDA   C54450   Patient Problem   Codes FDA CDRH              C50410   Anaphylactoid
FDA   C54450   Patient Problem   Codes FDA CDRH              C50417   Anastomose, Failure To
FDA   C54450   Patient Problem   Codes FDA CDRH              C2869    Anemia
FDA   C54450   Patient Problem   Codes FDA CDRH              C51220   Anesthesia, insufficient, light or patchy                                                        Light, patchy or insufficient anesthesia|Patchy, light or insufficient anesthesia|Insufficient, light or patchy anesthesia
FDA   C54450   Patient Problem   Codes FDA CDRH              C26693   Aneurysm
FDA   C54450   Patient Problem   Codes FDA CDRH              C51221   Angina
FDA   C54450   Patient Problem   Codes FDA CDRH              C2876    Anoxia
FDA   C54450   Patient Problem   Codes FDA CDRH              C51222   Antibiotics, reaction to
FDA   C54450   Patient Problem   Codes FDA CDRH              C26696   Anxiety
FDA   C54450   Patient Problem   Codes FDA CDRH              C50461   Aortic Dissection                                                                                Dissection, Aortic
FDA   C54450   Patient Problem   Codes FDA CDRH              C51223   Aortic insufficiency
FDA   C54450   Patient Problem   Codes FDA CDRH              C50861   Aortic Regurgitation                        The backward flow of blood from the aorta
                                                                                                                  into the left ventricle, owing to insufficiency of
                                                                                                                  the aortic semilunar valve; it may be chronic
                                                                                                                  or acute.
FDA   C54450   Patient Problem Codes FDA CDRH                C50462   Aortic Stenosis                             Narrowing of the orifice of the aortic valve or
                                                                                                                  of the supravalvular or subvalvular regions.

FDA   C54450   Patient Problem   Codes FDA CDRH              C50815   Aortic Valve Replacement                                                                         Replacement of aortic valve|Valve, replacement of aortic
FDA   C54450   Patient Problem   Codes FDA CDRH              C50416   Apgar Score, Decreased Or Low                                                                    Low or decreased apgar score|Score, decreased or low apgar|Decreased or low apgar score
FDA   C54450   Patient Problem   Codes FDA CDRH              C15191   Apheresis
FDA   C54450   Patient Problem   Codes FDA CDRH              C50824   Apicectomy
FDA   C54450   Patient Problem   Codes FDA CDRH              C26698   Apnea                                       Cessation of breathing.                              Respiratory Arrest|Arrest, respiratory
FDA   C54450   Patient Problem   Codes FDA CDRH              C50749   Arachnoiditis, Spinal                       A chronic adhesive arachnoiditis in the
                                                                                                                  spinal arachnoid, with root and spinal cord
                                                                                                                  symptoms similar to those caused by
                                                                                                                  pressure from a tumor.
FDA   C54450   Patient Problem   Codes FDA CDRH              C2881    Arrhythmia
FDA   C54450   Patient Problem   Codes FDA CDRH              C34398   Arteriosclerosis
FDA   C54450   Patient Problem   Codes FDA CDRH              C50464   Arthralgia                                  Pain in a joint.                                     Joint pain|Pain, joint
FDA   C54450   Patient Problem   Codes FDA CDRH              C2883    Arthritis
FDA   C54450   Patient Problem   Codes FDA CDRH              C2884    Arthritis, Rheumatoid                                                                            Rheumatoid Arthritis
FDA   C54450   Patient Problem   Codes FDA CDRH              C2885    Ascites
FDA   C54450   Patient Problem   Codes FDA CDRH              C50465   Asphyxia                                    A condition due to lack of oxygen in respired
                                                                                                                  air, resulting in impending or actual
                                                                                                                  cessation of life.
FDA   C54450   Patient Problem   Codes FDA CDRH              C28245   Aspiration
FDA   C54450   Patient Problem   Codes FDA CDRH              C28397   Asthma
FDA   C54450   Patient Problem   Codes FDA CDRH              C35768   Atherosclerosis
FDA   C54450   Patient Problem   Codes FDA CDRH              C50466   Atrial Fibrillation                         An arrhythmia in which minute areas of the
                                                                                                                  atrial myocardium are in various
                                                                                                                  uncoordinated stages of depolarization and
                                                                                                                  repolarization; instead of intermittently
                                                                                                                  contracting, the atria quiver continuously in a
                                                                                                                  chaotic pattern, causing a totally irregular,
                                                                                                                  often rapid ventricular rate.

FDA   C54450   Patient Problem   Codes FDA CDRH              C51224   Atrial Flutter
FDA   C54450   Patient Problem   Codes FDA CDRH              C50467   Atrial Perforation
FDA   C54450   Patient Problem   Codes FDA CDRH              C35481   Atrial Tachycardia
FDA   C54450   Patient Problem   Codes FDA CDRH              C2889    Autoimmune Disease                                                                               Disease, autoimmune
FDA   C54450   Patient Problem   Codes FDA CDRH              C16313   Autoimmune reaction                                                                              Reaction, autoimmune
FDA   C54450   Patient Problem   Codes FDA CDRH              C50870   Autotransfusion                             Reinfusion of blood or blood products
                                                                                                                  derived from the patient's own circulation.
FDA   C54450   Patient Problem   Codes FDA CDRH              C51225   Biliary Cirrhosis                                                                                Cirrhosis, biliary
FDA   C54450   Patient Problem   Codes FDA CDRH              C50551   Blinking, Excessive                                                                              Excessive blinking
FDA   C54450   Patient Problem   Codes FDA CDRH              C50447   Blood Gas Measurements, Abnormal                                                                 Measurements, abnormal blood gas|Abnormal blood gas measurements
FDA   C54450   Patient Problem   Codes FDA CDRH              C50470   Blood loss                                                                                       Loss of blood
FDA   C54450   Patient Problem   Codes FDA CDRH              C27123   Blurred vision                                                                                   Vision, Blurring Of|Blurring
FDA   C54450   Patient Problem   Codes FDA CDRH              C39611   Bowel Perforation
FDA   C54450   Patient Problem   Codes FDA CDRH              C37920   Bradycardia                                                                                      Decreased heart rate|Heart Rate, Decreased
FDA   C54450   Patient Problem   Codes FDA CDRH              C50440   Brain Injury                                                                                     Brain Damage|Injury, brain
FDA   C54450   Patient Problem   Codes FDA CDRH              C3197    Breast Lumps                                                                                     Lumps, breast
FDA   C54450   Patient Problem   Codes FDA CDRH              C2910    Breast Neoplasm                                                                                  Neoplasm, breast
FDA   C54450   Patient Problem   Codes FDA CDRH              C2911    Bronchitis
FDA   C54450   Patient Problem   Codes FDA CDRH              C26710   Bronchopneumonia
FDA   C54450   Patient Problem   Codes FDA CDRH              C34439   Bronchospasm
FDA   C54450   Patient Problem   Codes FDA CDRH              C37921   Bruise
FDA   C54450   Patient Problem   Codes FDA CDRH              C34441   Burn(s)                                     Injury to tissues caused by contact with dry
                                                                                                                  heat, moist heat, flames, chemicals,
                                                                                                                  electricity, friction or radiant and
                                                                                                                  electromagnetic energy. A first degree burn
                                                                                                                  is associated with redness, a second degree
                                                                                                                  burn with vesication and a third degree burn
                                                                                                                  with necrosis through the entire skin.

FDA   C54450   Patient Problem   Codes FDA CDRH              C50473   Burn, Bowel                                                                                      Bowel burn
FDA   C54450   Patient Problem   Codes FDA CDRH              C50506   Burn, Corneal                                                                                    Corneal burn
FDA   C54450   Patient Problem   Codes FDA CDRH              C50768   Burn, thermal                                                                                    Burns, Thermal|Thermal burn
FDA   C54450   Patient Problem   Codes FDA CDRH              C50476   Burning Sensation                                                                                Sensation, burning
FDA   C54450   Patient Problem   Codes FDA CDRH              C3672    Calcification                                                                                    Deposit(s), calcium|Calcium Deposit(s)
FDA   C54450   Patient Problem   Codes FDA CDRH   C4872    Cancer, Breast                                                                                   Breast cancer
FDA   C54450   Patient Problem   Codes FDA CDRH   C50477   Cancer, Other
FDA   C54450   Patient Problem   Codes FDA CDRH   C50702   Capsular Bag Tear, Posterior
FDA   C54450   Patient Problem   Codes FDA CDRH   C50479   Cardiac Arrest                                  Sudden cessation of the pumping function         Arrest, cardiac|Asystole
                                                                                                           of the heart, with disappearance of arterial
                                                                                                           blood pressure, connoting either ventricular
                                                                                                           fibrillation or ventricular standstill.

FDA   C54450   Patient Problem Codes FDA CDRH     C73502   Cardiac perforation
FDA   C54450   Patient Problem Codes FDA CDRH     C50481   Cardiac Tamponade                               Acute compression of the heart caused by
                                                                                                           increased intrapericardial pressure due to
                                                                                                           the collection of blood or fluid in the
                                                                                                           pericardium from rupture of the heart,
                                                                                                           penetrating trauma, or progressive effusion.

FDA   C54450   Patient Problem Codes FDA CDRH     C34830   Cardiomyopathy
FDA   C54450   Patient Problem Codes FDA CDRH     C50483   Cardiopulmonary Arrest                          Cessation of breathing and/or cardiac            Arrest, cardiopulmonary
                                                                                                           function.
FDA   C54450   Patient Problem Codes FDA CDRH     C26713   Cataract
FDA   C54450   Patient Problem Codes FDA CDRH     C50614   Cataract, Induced                               A cataract that has been produced artificially Induced cataract
                                                                                                           or by induction, e.g. as a result of device
                                                                                                           use, medication, trauma, tears, falls,
                                                                                                           accidental injury, etc.
FDA   C54450   Patient Problem Codes FDA CDRH     C34442   Caustic/Chemical Burns                                                                         Burn, caustic/chemical|Chemical/caustic burn
FDA   C54450   Patient Problem Codes FDA CDRH     C26715   Cellulitis
FDA   C54450   Patient Problem Codes FDA CDRH     C50484   Cephalohematoma                                 A subperiosteal hemorrhage limited to the
                                                                                                           surface of one cranial bone, a usually benign
                                                                                                           condition seen in the newborn as a result of
                                                                                                           bone trauma.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50803   Cerebral ventriculomegalia                                                                       Ventriculomeglia
FDA   C54450   Patient Problem   Codes FDA CDRH   C50487   Cerebrospinal Fluid Leakage                                                                      Fluid, leakage of cerebrospinal|Leakage of cerebrospinal fluid
FDA   C54450   Patient Problem   Codes FDA CDRH   C3390    Cerebrovascular Accident                                                                         Syndrome, stroke|Stroke Syndrome|Stroke|CVA|CVA, Cerebrovascular accident|Cerebrovascular accident, (CVA)
FDA   C54450   Patient Problem   Codes FDA CDRH   C50488   Cervical Changes                                Changes such as abnormal, pathological,          Cervical Change|Changes, cervical
                                                                                                           benign, malignant, etc.
FDA   C54450   Patient Problem Codes FDA CDRH     C46088   Cesarean Section (c-section)                                                                     Delivery by cesarean section (c-section)|C-section (cesarean section), delivery by
FDA   C54450   Patient Problem Codes FDA CDRH     C36290   Chemical Exposure                                                                                Exposure, chemical
FDA   C54450   Patient Problem Codes FDA CDRH     C50490   Chemosis                                        Excessive edema of the ocular conjunctiva.

FDA   C54450   Patient Problem   Codes FDA CDRH   C38665   Chest Pain                                                                                       Pain in chest
FDA   C54450   Patient Problem   Codes FDA CDRH   C50491   Chest Tightness/Pressure                                                                         Tightness/pressure in chest|Pressure/tightness in chest
FDA   C54450   Patient Problem   Codes FDA CDRH   C35143   Chills
FDA   C54450   Patient Problem   Codes FDA CDRH   C50494   Choking
FDA   C54450   Patient Problem   Codes FDA CDRH   C26720   Chorioamnionitis
FDA   C54450   Patient Problem   Codes FDA CDRH   C3199    Chronic obstructive pulmonary disease, (COPD)                                                    COPD, chronic obstructive pulmonary disease|Pulmonary disease (COPD), chronic obstructive|Obstructive pulmonary disease (COPD), chronic|Disease (COPD), chronic obstructive
FDA   C54450   Patient Problem   Codes FDA CDRH   C50495   Claudication                                    Limping or lameness.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50834   Closed Capsulotomy
FDA   C54450   Patient Problem   Codes FDA CDRH   C34455   Clouding, Central Corneal                       Diffuse edema of the central region of the    Corneal clouding, central|Central corneal clouding
                                                                                                           cornea, usually associated with the wearing
                                                                                                           of hard contact lenses, but may also occur in
                                                                                                           keratoconus.
FDA   C54450   Patient Problem Codes FDA CDRH     C2902    Coagulopathy
FDA   C54450   Patient Problem Codes FDA CDRH     C50457   Cognitive Changes                               Pertaining to or characterized by cognition. Changes, cognitive
                                                                                                           That operation of the mind which we become
                                                                                                           aware of objects of thought or perception; it
                                                                                                           includes all aspects of perceiving, thinking,
                                                                                                           or remembering.

FDA   C54450   Patient Problem   Codes FDA CDRH   C50497   Collapse
FDA   C54450   Patient Problem   Codes FDA CDRH   C15211   Colostomy
FDA   C54450   Patient Problem   Codes FDA CDRH   C34497   Coma                                                                                             Comatose
FDA   C54450   Patient Problem   Codes FDA CDRH   C50499   Complaint, Ill-Defined                                                                           Ill-defined complaint
FDA   C54450   Patient Problem   Codes FDA CDRH   C50501   Complete Heart Block
FDA   C54450   Patient Problem   Codes FDA CDRH   C50502   Concussion                                      A violent jar or shock, or the condition which
                                                                                                           results from such an injury.
FDA   C54450   Patient Problem   Codes FDA CDRH   C37928   Confusion/Disorientation                                                                         Disorientation/confusion
FDA   C54450   Patient Problem   Codes FDA CDRH   C2849    Congenital Defect/Deformity                                                                      Deformity/defect, congenital|Defect/deformity, congenital
FDA   C54450   Patient Problem   Codes FDA CDRH   C3080    Congestive Heart Failure                                                                         Failure, congestive heart|Heart failure, congestive
FDA   C54450   Patient Problem   Codes FDA CDRH   C34504   Conjunctivitis
FDA   C54450   Patient Problem   Codes FDA CDRH   C26729   Connective Tissue Disease                                                                     Tissue disease, connective|Disease, connective tissue
FDA   C54450   Patient Problem   Codes FDA CDRH   C50441   Contusion                                       A bruise; an injury of a part without a break
                                                                                                           in the skin.
FDA   C54450   Patient Problem Codes FDA CDRH     C50496   Convulsion, Clonic                              A convulsion marked by alternating            Clonic convulsion
                                                                                                           contracting and relaxing of the muscles.
FDA   C54450   Patient Problem Codes FDA CDRH     C50776   Convulsion, Tonic                               Prolonged contraction of the muscles, as the Tonic convulsion
                                                                                                           result of an epileptic discharge.
FDA   C54450   Patient Problem Codes FDA CDRH     C50692   Cornea, Perforation Of                                                                        Perforation of cornea
FDA   C54450   Patient Problem Codes FDA CDRH     C26730   Corneal Abrasion
FDA   C54450   Patient Problem Codes FDA CDRH     C50507   Corneal Decompensation                          Inability to maintain corneal integrity; or      Decompensation, corneal
                                                                                                           corneal edema resulting from failure of the
                                                                                                           corneal endothelium to maintain
                                                                                                           detumescence.
FDA   C54450   Patient Problem Codes FDA CDRH     C50508   Corneal Edema                                   Hazy, swollen cornea.                         Edema, corneal
FDA   C54450   Patient Problem Codes FDA CDRH     C50509   Corneal haze                                                                                  Haze
FDA   C54450   Patient Problem Codes FDA CDRH     C50510   Corneal Infiltrates                             Discrete, small lesions present in the cornea Infiltrates, corneal
                                                                                                           as a result of corneal inflammation and, in
                                                                                                           some cases, after soft contact lens wear
                                                                                                           especially extended-wear lenses.

FDA   C54450   Patient Problem Codes FDA CDRH     C50511   Corneal Scar                                                                                    Scar, corneal
FDA   C54450   Patient Problem Codes FDA CDRH     C50513   Corneal Touch                                   Complications of intraocular lens surgery;      Touch, corneal
                                                                                                           usually refers to intraocular lens contact with
                                                                                                           cornea, can be intermittent or chronic.

FDA   C54450   Patient Problem Codes FDA CDRH     C50514   Corneal Transplant                                                                               Transplant, corneal
FDA   C54450   Patient Problem Codes FDA CDRH     C50515   Corneal Ulcer                                   Area of epithelial tissue loss from corneal      Ulcer, corneal
                                                                                                           surface; associated with inflammatory cells
                                                                                                           in the cornea and anterior chamber.
FDA   C54450   Patient Problem Codes FDA CDRH     C34827   Cramp(s)
FDA   C54450   Patient Problem Codes FDA CDRH     C50505   Cross-patient exposure to body fluids           The patient becomes contaminated from            Blood/fluids, contamination from|Fluids/blood, contamination from|Contamination From Blood/Fluids
                                                                                                           contact with blood/fluids on a device.
FDA   C54450   Patient Problem   Codes FDA CDRH   C35375   Crushing Injury                                                                                  Injury, crushing
FDA   C54450   Patient Problem   Codes FDA CDRH   C50517   Cusp Tear
FDA   C54450   Patient Problem   Codes FDA CDRH   C26737   Cyanosis
FDA   C54450   Patient Problem   Codes FDA CDRH   C50519   Cyclitis                                        Inflammation of the ciliary body.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50520   Cyst(s), Formation Of                                                                            Formation of cyst(s)
FDA   C54450   Patient Problem   Codes FDA CDRH   C50521   Cytomegaloviral Retinitis                                                                        Retinitis, cytomegaloviral
FDA   C54450   Patient Problem   Codes FDA CDRH   C14196   Cytomegalovirus (CVM)                                                                            CMV, cytomegalovirus
FDA   C54450   Patient Problem   Codes FDA CDRH   C27644   Deafness
FDA   C54450   Patient Problem   Codes FDA CDRH   C50620   Death, Intrauterine Fetal                       Death in utero; failure of the product of        Intrauterine fetal death|Fetal death, intrauterinel
                                                                                                           conception to show evidence of respiration,
                                                                                                           heart beat, or definite movement of a
                                                                                                           voluntary muscle after expulsion from the
                                                                                                           uterus, with no possibility of resuscitation.

FDA   C54450   Patient Problem Codes FDA CDRH     C50418   Death/Expired                                                                                    Expired/death
FDA   C54450   Patient Problem Codes FDA CDRH     C50472   Debris, Bone Shedding                           Shedding of accumulated bone fragments.          Bone shedding debris|Shedding of bone debris

FDA   C54450   Patient Problem   Codes FDA CDRH   C50923   Decreased Apgar
FDA   C54450   Patient Problem   Codes FDA CDRH   C73504   Decreased sensitivity
FDA   C54450   Patient Problem   Codes FDA CDRH   C50527   Dehiscence of organ                                                                              Dehiscence
FDA   C54450   Patient Problem   Codes FDA CDRH   C26740   Dehydrated
FDA   C54450   Patient Problem   Codes FDA CDRH   C4786    Dementia
FDA   C54450   Patient Problem   Codes FDA CDRH   C50531   Dementia, Dialysis                              A severe, often fatal encephalopathy which       Dialysis dementia
                                                                                                           has been attributed to accumulation in the
                                                                                                           brain of aluminum from dialysate prepared
                                                                                                           with inadequately purified water.

FDA   C54450   Patient Problem Codes FDA CDRH     C9442    Deposits
FDA   C54450   Patient Problem   Codes FDA CDRH   C2982    Depression
FDA   C54450   Patient Problem   Codes FDA CDRH   C26744   Dermatomyositis
FDA   C54450   Patient Problem   Codes FDA CDRH   C26874   Detached retina                                                                             Retina, detached
FDA   C54450   Patient Problem   Codes FDA CDRH   C50530   Diabetic Ketoacidosis                          A type of metabolic acidosis produced by     Ketoacidosis, diabetic
                                                                                                          accumulation of ketone bodies resulting from
                                                                                                          uncontrolled diabetes mellitus.
FDA   C54450   Patient Problem Codes FDA CDRH     C50403   Diaphoretic                                    Pertaining to or characterized by, or
                                                                                                          promoting diaphoresis; an agent that
                                                                                                          produces diaphoresis. (Diaphoresis is the
                                                                                                          act of perspiration, especially profuse
                                                                                                          perspiration).
FDA   C54450   Patient Problem   Codes FDA CDRH   C2987    Diarrhea
FDA   C54450   Patient Problem   Codes FDA CDRH   C50492   Difficulty Chewing
FDA   C54450   Patient Problem   Codes FDA CDRH   C21007   Disability
FDA   C54450   Patient Problem   Codes FDA CDRH   C50707   Disc Impingement
FDA   C54450   Patient Problem   Codes FDA CDRH   C50437   Discharge
FDA   C54450   Patient Problem   Codes FDA CDRH   C50535   Discomfort
FDA   C54450   Patient Problem   Codes FDA CDRH   C50536   Disfigurement
FDA   C54450   Patient Problem   Codes FDA CDRH   C61409   Dissection
FDA   C54450   Patient Problem   Codes FDA CDRH   C2992    Disseminated intravascular coagulation (DIC)   A disorder characterized by reduction in the       Coagulation (DIC), disseminated intravascular|DIC|DIC, disseminated intravascular coagulation|Disseminated intravascular coagulation|Intravascular coagulation (DIC), disseminated
                                                                                                          elements involved in blood coagulation due
                                                                                                          to their utilization in widespread blood
                                                                                                          clotting within the vessels.

FDA   C54450   Patient Problem   Codes FDA CDRH   C50537   Distention
FDA   C54450   Patient Problem   Codes FDA CDRH   C37942   Distress
FDA   C54450   Patient Problem   Codes FDA CDRH   C37943   Dizziness
FDA   C54450   Patient Problem   Codes FDA CDRH   C34553   Dry Eye(s)                                                                                        Eye(s), dry
FDA   C54450   Patient Problem   Codes FDA CDRH   C50539   Dyskinesia                                     Difficulty moving; distortion or impairment of
                                                                                                          voluntary movement, as in tic, spasm, or
                                                                                                          myoclonus.
FDA   C54450   Patient Problem   Codes FDA CDRH   C2980    Dysphagia
FDA   C54450   Patient Problem   Codes FDA CDRH   C35546   Dysphasia
FDA   C54450   Patient Problem   Codes FDA CDRH   C2998    Dyspnea                                                                                           Breathing Difficulties|Difficulty breathing
FDA   C54450   Patient Problem   Codes FDA CDRH   C2999    Dysuria                                        Difficulty or pain in urination.
FDA   C54450   Patient Problem   Codes FDA CDRH   C26758   Ecchymosis
FDA   C54450   Patient Problem   Codes FDA CDRH   C34945   Ectopic Pregnancy                                                                                 Pregnancy, ectopic
FDA   C54450   Patient Problem   Codes FDA CDRH   C3002    Edema
FDA   C54450   Patient Problem   Codes FDA CDRH   C35468   Edema, macular                                                                                    Macular edema
FDA   C54450   Patient Problem   Codes FDA CDRH   C50901   Edema, Microcystic                                                                                Microcystic edema
FDA   C54450   Patient Problem   Codes FDA CDRH   C50859   Edema, Stromal                                 Fluid from the aqueous humor enters the            Stromal edema
                                                                                                          corneal stroma and causes swelling.
FDA   C54450   Patient Problem Codes FDA CDRH     C50543   EKG/ECG Changes                                Changes in cardiac electrical activity.       Changes in EKG/ECG|ECG/EKG changes
FDA   C54450   Patient Problem Codes FDA CDRH     C50541   Electric Shock                                                                               Electrical Shock|Shock, electric|Shock, Electrical
FDA   C54450   Patient Problem Codes FDA CDRH     C50544   Electrocution                                  The passage of electrical current through the
                                                                                                          body.
FDA   C54450   Patient Problem Codes FDA CDRH     C50545   Electrolyte Imbalance                          Higher or lower than normal values for the    Imbalance, electrolyte
                                                                                                          serum electrolytes; usually affecting NA, K,
                                                                                                          CHL, CO2, glucose, bun.
FDA   C54450   Patient Problem Codes FDA CDRH     C50542   Electro-Mechanical Dissociation                Continued electrical rhythmicity of the heart Dissociation, electro-mechanical
                                                                                                          in the absence of effective mechanical
                                                                                                          function.
FDA   C54450   Patient Problem Codes FDA CDRH     C26759   Embolism
FDA   C54450   Patient Problem Codes FDA CDRH     C50547   Embolus                                        A mass of clotted blood or other formed
                                                                                                          elements, such as bubbles of air, calcium
                                                                                                          fragments, etc. brought by the blood from
                                                                                                          another vessel and forced into a smaller one,
                                                                                                          thus obstructing the circulation.
FDA   C54450   Patient Problem Codes FDA CDRH     C50489   Emotional Changes                                                                                 Changes, emotional
FDA   C54450   Patient Problem Codes FDA CDRH     C3348    Emphysema, Pulmonary                           A condition of the lung characterized by           Pulmonary emphysema
                                                                                                          increase beyond normal in the size of air
                                                                                                          spaces distal to the terminal bronchioles,
                                                                                                          either from dilatation of the alveoli or from
                                                                                                          destruction of their walls.
FDA   C54450   Patient Problem   Codes FDA CDRH   C26760   Encephalitis
FDA   C54450   Patient Problem   Codes FDA CDRH   C26920   Encephalopathy
FDA   C54450   Patient Problem   Codes FDA CDRH   C34582   Endocarditis
FDA   C54450   Patient Problem   Codes FDA CDRH   C34586   Endophthalmitis
FDA   C54450   Patient Problem   Codes FDA CDRH   C50548   Entrapment                                     Patient becomes entangled or caught in a
                                                                                                          bed, particularly in side rails, or mattress, or
                                                                                                          head/foot boards.
FDA   C54450   Patient Problem Codes FDA CDRH     C50480   Enzyme Elevation, Cardiac                                                                         Cardiac enzyme elevation|Elevation of cardiac enzymes
FDA   C54450   Patient Problem Codes FDA CDRH     C50443   Erosion                                        An eating away or breakdown of any type of
                                                                                                          external or internal human tissue including
                                                                                                          but not limited to skin, teeth, mucosa, or
                                                                                                          somatic, which involves only the outer tissue
                                                                                                          layer. When tissue surrounds an implanted
                                                                                                          device, the tissue breakdown may result in
                                                                                                          migration and loss of the implant material
                                                                                                          and may result in further complications such
                                                                                                          as infection or abscess.

FDA   C54450   Patient Problem Codes FDA CDRH     C50550   Eructate                                       To belch, the casting of upwind from the
                                                                                                          stomach.
FDA   C54450   Patient Problem   Codes FDA CDRH   C26901   Erythema
FDA   C54450   Patient Problem   Codes FDA CDRH   C50841   Esophagus, Laceration(s) Of                                                                       Laceration(s) of esophagus
FDA   C54450   Patient Problem   Codes FDA CDRH   C50693   Esophagus, Perforation Of                                                                         Perforation of esophagus
FDA   C54450   Patient Problem   Codes FDA CDRH   C50553   Exit Block
FDA   C54450   Patient Problem   Codes FDA CDRH   C50856   Exsanguination                                 Extensive loss of blood due to internal or
                                                                                                          external hemorrhage.
FDA   C54450   Patient Problem Codes FDA CDRH     C48198   Extravasation                                  A discharge or escape, as of blood, from a
                                                                                                          vessel into the tissues.
FDA   C54450   Patient Problem Codes FDA CDRH     C50556   Extreme Exhaustion                             Extreme fatigue; inability to respond to           Exhaustion, extreme
                                                                                                          stimuli.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50819   Extubate
FDA   C54450   Patient Problem   Codes FDA CDRH   C34602   Eye injury                                                                                        Injury, eye
FDA   C54450   Patient Problem   Codes FDA CDRH   C26769   Facial Nerve Paralysis                                                                            Paralysis of facial nerve|Nerve paralysis, facial
FDA   C54450   Patient Problem   Codes FDA CDRH   C50857   Fainting
FDA   C54450   Patient Problem   Codes FDA CDRH   C50558   Fall
FDA   C54450   Patient Problem   Codes FDA CDRH   C50559   Fasciitis                                      Inflammation of fascia.
FDA   C54450   Patient Problem   Codes FDA CDRH   C3036    Fatigue
FDA   C54450   Patient Problem   Codes FDA CDRH   C50560   Feeding Problems                                                                                  Problems, feeding
FDA   C54450   Patient Problem   Codes FDA CDRH   C50563   Fetal Distress                                                                                    Distress, fetal
FDA   C54450   Patient Problem   Codes FDA CDRH   C3038    Fever
FDA   C54450   Patient Problem   Codes FDA CDRH   C50566   Fibromyositis                                  Inflammation and fibrous degeneration of a
                                                                                                          muscle.
FDA   C54450   Patient Problem Codes FDA CDRH     C3044    Fibrosis                                       The formation of fibrous tissue; fibroid or
                                                                                                          fibrous degeneration.
FDA   C54450   Patient Problem Codes FDA CDRH     C50532   First Use Syndrome                             A symptom complex characterized by                 Syndrome, first use
                                                                                                          nervousness, chest pain, back pain,
                                                                                                          palpations, pruritus, and other usually mild
                                                                                                          symptoms occurring minutes following the
                                                                                                          initiation of dialysis with a new dialyzer.

FDA   C54450   Patient Problem   Codes FDA CDRH   C3045    Fistula
FDA   C54450   Patient Problem   Codes FDA CDRH   C50568   Flashers                                       A sudden or brief burst of light.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50569   Flatus                                         Gas or air in the gastrointestinal tract.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50570   Follow-Up Bowel Resection Required
FDA   C54450   Patient Problem   Codes FDA CDRH   C50524   Forced Expiratory Volume, Decreased            A decrease in the fraction of the forced vital FEV (forced expiratory volume), decreased|Forced expiratory volume (FEV), decreased|Volume (FEV), decreased forced expiratory|FEV decreased|Decreased forced expiratory volume (FEV)
                                                                                                          capacity that is exhaled in a specific number
                                                                                                          of seconds.
FDA   C54450   Patient Problem Codes FDA CDRH     C50609   Forced Expiratory Volume, Increased            An increase in the fraction of the forced vital FEV increased|Forced expiratory volume (FEV), increased|FEV, (forced expiratory volume), increased|Volume (FEV), increased forced expiratory|Increased forced expiratory volume (FEV)
                                                                                                          capacity that is exhaled in a specific number
                                                                                                          of seconds.
FDA   C54450   Patient Problem Codes FDA CDRH     C34620   Foreign body
FDA   C54450   Patient Problem Codes FDA CDRH     C50444   Foreign Body Reaction               A granulomatous inflammatory reaction         Reaction, foreign body
                                                                                               evoked by the presence of an exogenous
                                                                                               material in the tissues, a characteristic
                                                                                               feature of which is the formation of foreign
                                                                                               body giant cells.
FDA   C54450   Patient Problem Codes FDA CDRH     C50572   Foreign Body Sensation              Feeling of grittiness or having something in Sensation, foreign body
                                                                                               the eye; frequently caused by a foreign body.
                                                                                               Other possible causes include corneal
                                                                                               abrasion, corneal ulcer, inturned eye lash or
                                                                                               acute conjunctivitis.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50821   Foreign Body, Removal Of                                                          Removal of foreign body
FDA   C54450   Patient Problem   Codes FDA CDRH   C3046    Fracture(s)
FDA   C54450   Patient Problem   Codes FDA CDRH   C27783   Fracture, Arm
FDA   C54450   Patient Problem   Codes FDA CDRH   C50529   Fracture, Delayed Union                                                              Delayed union fracture|Union fracture, delayed
FDA   C54450   Patient Problem   Codes FDA CDRH   C26794   Fracture, Hip                                                                        Hip fracture
FDA   C54450   Patient Problem   Codes FDA CDRH   C50745   Fracture, Skull                                                                      Skull fracturel
FDA   C54450   Patient Problem   Codes FDA CDRH   C50777   Fracture, Tooth                                                                      Tooth fracture
FDA   C54450   Patient Problem   Codes FDA CDRH   C14209   Fungus
FDA   C54450   Patient Problem   Codes FDA CDRH   C50573   Gangrene                            Death of tissue, usually in considerable
                                                                                               mass and generally associated with loss of
                                                                                               vascular (nutritive) supply and followed by
                                                                                               bacterial invasion and putrefaction.
FDA   C54450   Patient Problem   Codes FDA CDRH   C26780   Gastritis
FDA   C54450   Patient Problem   Codes FDA CDRH   C26782   Glaucoma
FDA   C54450   Patient Problem   Codes FDA CDRH   C3064    Granuloma
FDA   C54450   Patient Problem   Codes FDA CDRH   C52352   Great Vessel Perforation                                                             Perforation, great vessel
FDA   C54450   Patient Problem   Codes FDA CDRH   C50575   Hair Loss                                                                            Loss of hair
FDA   C54450   Patient Problem   Codes FDA CDRH   C50806   Halo                                Hazy ring around bright lights seen by some
                                                                                               patients with refractive error or optical
                                                                                               defects, e.g. cataracts, or corneal swelling.

FDA   C54450   Patient Problem Codes FDA CDRH     C34660   Head Injury                                                                          Injury, head
FDA   C54450   Patient Problem Codes FDA CDRH     C34661   Headache
FDA   C54450   Patient Problem Codes FDA CDRH     C50643   Headache, Lumbar Puncture           Headache in erect position, after lumbar         Headache, post spinal|Lumbar puncture headache|Post spinal headache
                                                                                               puncture; due to lowering of intracranial
                                                                                               pressure by leakage of cerebrospinal fluid
                                                                                               through the needle tract.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50601   Healing, Impaired                                                                    Impaired healing
FDA   C54450   Patient Problem   Codes FDA CDRH   C50576   Hearing Impairment                                                                   Impairment, hearing
FDA   C54450   Patient Problem   Codes FDA CDRH   C35731   Hearing loss                                                                         Loss of hearing
FDA   C54450   Patient Problem   Codes FDA CDRH   C50577   Heart Failure                       Inability of the heart to pump blood at an       Cardiac Insufficiency|Failure, Heart|Insufficiency, cardiac
                                                                                               adequate rate to fill tissue metabolic
                                                                                               requirements or the ability to do so only at
                                                                                               an elevated filling pressure.
FDA   C54450   Patient Problem Codes FDA CDRH     C34670   Heartburn
FDA   C54450   Patient Problem Codes FDA CDRH     C50578   Heavier Menses
FDA   C54450   Patient Problem Codes FDA CDRH     C50579   Hematoma                            A localized collection of blood, usually
                                                                                               clotted, in an organ, space, or tissue, due to
                                                                                               a break in the wall of a blood vessel.
FDA   C54450   Patient Problem Codes FDA CDRH     C3090    Hematuria
FDA   C54450   Patient Problem Codes FDA CDRH     C50580   Hemoconcentration                   An increase in the concentration of blood
                                                                                               cells resulting from the loss of plasma or
                                                                                               water from the blood stream.
FDA   C54450   Patient Problem   Codes FDA CDRH   C15248   Hemodialysis
FDA   C54450   Patient Problem   Codes FDA CDRH   C37965   Hemolysis
FDA   C54450   Patient Problem   Codes FDA CDRH   C34376   Hemolytic Anemia                                                                     Anemia, hemolytic
FDA   C54450   Patient Problem   Codes FDA CDRH   C3094    Hemoptysis
FDA   C54450   Patient Problem   Codes FDA CDRH   C26791   Hemorrhage                                                                           Bleeding
FDA   C54450   Patient Problem   Codes FDA CDRH   C50485   Hemorrhage, cerebral                Hemorrhage into the cerebrum. See also           Bleeding, cerebral|Cerebral hemorrhage|Cerebral bleeding
                                                                                               Stroke Syndrome.
FDA   C54450   Patient Problem Codes FDA CDRH     C50555   Hemorrhage, Extradural              Intracranial hemorrhage into the epidural        Extradural hemorrhage
                                                                                               space.
FDA   C54450   Patient Problem Codes FDA CDRH     C50896   Hemorrhage, Intraventricular                                                         Intraventricular hemorrhage
FDA   C54450   Patient Problem Codes FDA CDRH     C50757   Hemorrhage, Subarachnoid            Intracranial hemorrhage into the                 Subarachnoid hemorrhage
                                                                                               subarachnoid space.
FDA   C54450   Patient Problem Codes FDA CDRH     C50759   Hemorrhage, Subdural                Cerebral hemorrhage into the subdural            Subdural hemorrhage
                                                                                               space. See also Stroke Syndrome.
FDA   C54450   Patient Problem Codes FDA CDRH     C50761   Hemorrhage, Subgaleal                                                                Hemorrhage, subgaleal
FDA   C54450   Patient Problem Codes FDA CDRH     C50581   Hemostasis                          The arrest of bleeding, either by the
                                                                                               physiological properties of vasoconstriction
                                                                                               and coagulation or by surgical means.

FDA   C54450   Patient Problem   Codes FDA CDRH   C50582   Hemothorax                          A collection of blood in the pleural cavity.
FDA   C54450   Patient Problem   Codes FDA CDRH   C3095    Hepatitis
FDA   C54450   Patient Problem   Codes FDA CDRH   C34685   Hernia
FDA   C54450   Patient Problem   Codes FDA CDRH   C50583   Herpes                              Any inflammatory skin disease caused by a
                                                                                               herpesvirus and characterized by the
                                                                                               formation of small vesicles in clusters.
FDA   C54450   Patient Problem Codes FDA CDRH     C37966   Hiccups
FDA   C54450   Patient Problem Codes FDA CDRH     C14219   HIV, Human Immunodeficiency Virus   A cytopathic retrovirus. It is the etiological   Virus (HIV), human immunodeficiency|Human immunodeficiency virus (HIV)
                                                                                               agent of AIDS.
FDA   C54450   Patient Problem Codes FDA CDRH     C50414   Hospitalization Required                                                         Required hospitalization
FDA   C54450   Patient Problem Codes FDA CDRH     C50586   Host-Tissue Reaction                Growth of tissue in or around a foreign body Tissue, reaction of host|Reaction of host-tissue
                                                                                               as the body's antibody response to the
                                                                                               foreign body.
FDA   C54450   Patient Problem Codes FDA CDRH     C3109    Hot Flashes                                                                      Flashes, hot
FDA   C54450   Patient Problem Codes FDA CDRH     C27088   Hyperbilirubinemia                  Excessive concentrations of bilirubin in the
                                                                                               blood, which may lead to jaundice.
FDA   C54450   Patient Problem Codes FDA CDRH     C50588   Hyperemia                           The presence of an increased amount of
                                                                                               blood in a part or organ; engorgement.
FDA   C54450   Patient Problem   Codes FDA CDRH   C26797   Hyperglycemia                                                                    Blood Glucose, High|High blood glucose|Glucose, high blood
FDA   C54450   Patient Problem   Codes FDA CDRH   C37970   Hypernatremia
FDA   C54450   Patient Problem   Codes FDA CDRH   C3113    Hyperplasia
FDA   C54450   Patient Problem   Codes FDA CDRH   C3114    Hypersensitivity                    Hypersensitivity; a local or general reaction    Allergic Reaction
                                                                                               of an organism following contact with a
                                                                                               specific allergen to which it has been
                                                                                               previously exposed and to which it has
                                                                                               become sensitized.
FDA   C54450   Patient Problem Codes FDA CDRH     C3117    Hypertension                                                                         Blood Pressure, High|Pressure, high blood|Blood Pressure, Increased|Increased blood pressure|High blood pressure
FDA   C54450   Patient Problem Codes FDA CDRH     C50589   Hyperthermia
FDA   C54450   Patient Problem Codes FDA CDRH     C50590   Hyperventilation                    Abnormally prolonged, rapid, and deep
                                                                                               breathing.
FDA   C54450   Patient Problem Codes FDA CDRH     C50591   Hypervolemia
FDA   C54450   Patient Problem Codes FDA CDRH     C50592   Hyphema                             Hemorrhage within the anterior chamber of
                                                                                               the eye; bloodshot.
FDA   C54450   Patient Problem Codes FDA CDRH     C50445   Hypoesthesia                        Consisting of abnormally decreased
                                                                                               sensitivity, particularly to touch.
FDA   C54450   Patient Problem Codes FDA CDRH     C50463   Hypoesthesia, Arm/Hand              Consisting of abnormally decreased
                                                                                               sensitivity, particularly to touch.
FDA   C54450   Patient Problem Codes FDA CDRH     C50571   Hypoesthesia, Foot/Leg              Consisting of abnormally decreased               Foot/leg hypoesthesia|Leg/foot hypoesthesia
                                                                                               sensitivity, particularly to touch.
FDA   C54450   Patient Problem Codes FDA CDRH     C3126    Hypoglycemia                                                                         Blood Glucose, Low|Low blood glucose|Glucose, low blood
FDA   C54450   Patient Problem Codes FDA CDRH     C50593   Hypopyon                            An accumulation of pus in the anterior
                                                                                               chamber of the eye.
FDA   C54450   Patient Problem Codes FDA CDRH     C3128    Hypotension                                                                          Blood Pressure, Decreased|Pressure, low blood|Decreased blood pressure|Low blood pressure|Blood Pressure, Low
FDA   C54450   Patient Problem Codes FDA CDRH     C50523   Hypothermia                         Abnormally low body temperature.                 Body temperature, decreased|Temperature, decreased body|Decreased body temperature
FDA   C54450   Patient Problem Codes FDA CDRH     C50594   Hypoventilation                     A state in which there is a reduced amount
                                                                                               of air entering the pulmonary alveoli.

FDA   C54450   Patient Problem Codes FDA CDRH     C50595   Hypovolemia                         Abnormally decreased volume of circulating
                                                                                               fluid (plasma) in body.
FDA   C54450   Patient Problem Codes FDA CDRH     C3890    Hypoxia
FDA   C54450   Patient Problem Codes FDA CDRH     C50564   Hypoxia, Fetal                      Hypoxia in utero, caused by conditions such
                                                                                               as inadequate placental function (often
                                                                                               abruptio placentae), preeclamptic toxicity,
                                                                                               prolapse of the umbilical cord, or
                                                                                               complications from anesthetic
                                                                                               administration.
FDA   C54450   Patient Problem Codes FDA CDRH     C50598   Iatrogenic Source                                                                             Source, iatogenic
FDA   C54450   Patient Problem Codes FDA CDRH     C50839   Identified Diagnosis                                                                          Diagnosis, identified
FDA   C54450   Patient Problem Codes FDA CDRH     C50599   Idioventricular Rhythm                        Relating to or affecting the cardiac ventricles Rhythm, idioventricular
                                                                                                         alone.
FDA   C54450   Patient Problem Codes FDA CDRH     C3131    Immuno-Deficiency                             A deficiency of immune response or a
                                                                                                         disorder characterized by deficient immune
                                                                                                         response.
FDA   C54450   Patient Problem Codes FDA CDRH     C50603   Implant, Failure Of                           An object or material, such as an alloplastic Failure of implant
                                                                                                         or radioactive material or tissue, partially or
                                                                                                         totally inserted or grafted into the body for
                                                                                                         prosthetic, therapeutic, diagnostic, or
                                                                                                         experimental purposes.

FDA   C54450   Patient Problem   Codes FDA CDRH   C3133    Impotence
FDA   C54450   Patient Problem   Codes FDA CDRH   C50415   Improved Patient Condition                                                                    Condition of patient, improved|Patient condition, improved
FDA   C54450   Patient Problem   Codes FDA CDRH   C50914   Inadequate Osteointegration
FDA   C54450   Patient Problem   Codes FDA CDRH   C50607   Incompetent Cervix                            One that is abnormally prone to dilate in the Cervix, incompetent
                                                                                                         second trimester of pregnancy, resulting in
                                                                                                         premature expulsion of the fetus.

FDA   C54450   Patient Problem Codes FDA CDRH     C3429    Incontinence
FDA   C54450   Patient Problem Codes FDA CDRH     C73503   Increased sensitivity                                                                         Sensitivity
FDA   C54450   Patient Problem Codes FDA CDRH     C50486   Infarction, cerebral                          An ischemic condition of the brain,             Cerebral, Infarction
                                                                                                         producing a persistent focal neurological
                                                                                                         deficit in the area of distribution of the
                                                                                                         cerebral arteries.
FDA   C54450   Patient Problem Codes FDA CDRH     C26726   Infection
FDA   C54450   Patient Problem Codes FDA CDRH     C2890    Infection, Bacterial                                                                          Bacterial infection
FDA   C54450   Patient Problem Codes FDA CDRH     C50534   Infection, Direct                             Infection produced by direct contact with       Direct infection
                                                                                                         another person.
FDA   C54450   Patient Problem Codes FDA CDRH     C3245    Infection, Fungal                                                                             Fungal infection
FDA   C54450   Patient Problem Codes FDA CDRH     C50612   Infection, Indirect                           Infection transmitted by water, food or other   Indirect infection
                                                                                                         means of conveyance.
FDA   C54450   Patient Problem Codes FDA CDRH     C50617   Infection, Intraocular                        Infection within the eye.                       Intraocular infection
FDA   C54450   Patient Problem Codes FDA CDRH     C50719   Infection, Pyrogenic                          An infection caused by pus-producing            Pyrogenic infection
                                                                                                         organisms.
FDA   C54450   Patient Problem Codes FDA CDRH     C50758   Infection, Subclinical                        Infection associated with no detectable         Subclinical infection
                                                                                                         symptoms but caused by microorganisms
                                                                                                         capable of producing easily recognizable
                                                                                                         diseases, such a poliomyelitis or mumps.

FDA   C54450   Patient Problem   Codes FDA CDRH   C35650   Infection, Upper Respiratory Tract
FDA   C54450   Patient Problem   Codes FDA CDRH   C50791   Infection, Urinary Tract                                                                      Urinary tract infection|Tract, infection of urinary
FDA   C54450   Patient Problem   Codes FDA CDRH   C3439    Infection, Viral                                                                              Viral infection
FDA   C54450   Patient Problem   Codes FDA CDRH   C50922   Infective Agents                                                                              Agents, infective
FDA   C54450   Patient Problem   Codes FDA CDRH   C25754   Infiltration of tissue                        To penetrate a tissue or substance.             Infiltration|Infiltrates
FDA   C54450   Patient Problem   Codes FDA CDRH   C3137    Inflammation
FDA   C54450   Patient Problem   Codes FDA CDRH   C3671    Injury
FDA   C54450   Patient Problem   Codes FDA CDRH   C50796   Insufficiency, Valvular                       Dysfunction of one of the cardiac valves, with Valvular insufficiency
                                                                                                         incomplete valve closure resulting in valvular
                                                                                                         regurgitation.
FDA   C54450   Patient Problem Codes FDA CDRH     C34818   Intermenstrual Bleeding
FDA   C54450   Patient Problem Codes FDA CDRH     C50616   Intimal Dissection                            Pertaining to the inner layer of the blood      Dissection, intimal
                                                                                                         vessels.
FDA   C54450   Patient Problem Codes FDA CDRH     C50438   Intracranial hemorrhage                       Bleeding within the cranium.                    Bleeding, Intracranial|Intracranial bleeding|Hemorrhage, Intracranial
FDA   C54450   Patient Problem Codes FDA CDRH     C50618   Intraocular Pressure Rise                     Increase of pressure of the intraocular fluid   IOPR|Intraocular pressure rise, (IOPR)|Pressure (IOPR), rise in intraocular|Rise in intraocular pressure, (IOPR)|IOPR, intraocular pressure rise
                                                                                                         in the eye.
FDA   C54450   Patient Problem Codes FDA CDRH     C50786   Intraocular Pressure, Delayed, Uncontrolled   Changes in the fluid pressure inside the eye.   Delayed, uncontrolled intraocular pressure (IOP)|IOP (intraocular pressure), delayed, uncontrolled|Intraocular pressure (IOP), delayed, uncontrolled|IOP Delayed, Uncontrolled|Pressure (IOP), delayed uncontrolled intraocular|Uncontrolled/delayed intraocular pressure (IOP)

FDA   C54450   Patient Problem   Codes FDA CDRH   C50619   Intraoperative Pain
FDA   C54450   Patient Problem   Codes FDA CDRH   C37981   Intubation
FDA   C54450   Patient Problem   Codes FDA CDRH   C50621   Iritis                                        Inflammation of the iris.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50623   Irritability
FDA   C54450   Patient Problem   Codes FDA CDRH   C50624   Irritation
FDA   C54450   Patient Problem   Codes FDA CDRH   C34738   Ischemia
FDA   C54450   Patient Problem   Codes FDA CDRH   C50625   Ischemic Heart Disease                                                                        Disease, ischemic heart|Heart disease, ischemic
FDA   C54450   Patient Problem   Codes FDA CDRH   C3344    Itching
FDA   C54450   Patient Problem   Codes FDA CDRH   C3143    Jaundice
FDA   C54450   Patient Problem   Codes FDA CDRH   C26750   Joint Dislocation                                                                             Dislocated joint
FDA   C54450   Patient Problem   Codes FDA CDRH   C35760   Joint Disorder                                                                                Disorder, joint
FDA   C54450   Patient Problem   Codes FDA CDRH   C50627   Joint Swelling                                                                                Swelling, joint
FDA   C54450   Patient Problem   Codes FDA CDRH   C26805   Keratitis
FDA   C54450   Patient Problem   Codes FDA CDRH   C50450   Keratitis, Acanthamoeba                       Keratitis due to infection by acanthamoeba; Acanthamoeba keratitis
                                                                                                         it is usually associated with soft contact lens
                                                                                                         wear, particularly overnight wear.

FDA   C54450   Patient Problem Codes FDA CDRH     C50917   Labor, Premature                              Ouster of a viable infant before the normal     Premature labor
                                                                                                         end of gestation, commonly defined as
                                                                                                         interruption of pregnancy between the
                                                                                                         twentieth-thirty seventh completed weeks
                                                                                                         after the onset of the last menstrual cycle.

FDA   C54450   Patient Problem   Codes FDA CDRH   C50446   Laceration(s)
FDA   C54450   Patient Problem   Codes FDA CDRH   C15266   Laparotomy
FDA   C54450   Patient Problem   Codes FDA CDRH   C61390   Lead(s), burn(s) from
FDA   C54450   Patient Problem   Codes FDA CDRH   C61392   Lead(s), shock from
FDA   C54450   Patient Problem   Codes FDA CDRH   C50629   Left Ventricular Dysfunction                                                                  Dysfunction, left ventricular|Ventricular dysfunction, left
FDA   C54450   Patient Problem   Codes FDA CDRH   C50630   Left Ventricular Failure                      Failure of adequate output by the left          Failure, left ventricular|Ventricular failure, left
                                                                                                         ventricle despite an increase in distending
                                                                                                         pressure and in end-diastolic volume, with
                                                                                                         dyspnea, orthopnea, and other signs and
                                                                                                         symptoms of pulmonary congestion and
                                                                                                         edema.
FDA   C54450   Patient Problem Codes FDA CDRH     C50631   Left Ventricular Hypertrophy                  Enlargement or overgrowth of the                Ventricular hypertrophy, left
                                                                                                         myocardium of the left ventricle, due to
                                                                                                         chronic pressure overload.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50836   Lens, Replacement Of
FDA   C54450   Patient Problem   Codes FDA CDRH   C50412   Lethargic
FDA   C54450   Patient Problem   Codes FDA CDRH   C50633   Ligament(s), Damage To                                                                        Damage to ligament(s)
FDA   C54450   Patient Problem   Codes FDA CDRH   C50909   Limited Mobility Of The Implanted Joint
FDA   C54450   Patient Problem   Codes FDA CDRH   C50853   Liver Contusion                               Bruising of the liver.                          Contusion, liver
FDA   C54450   Patient Problem   Codes FDA CDRH   C50634   Liver Dysfunction                                                                             Dysfunction, liver
FDA   C54450   Patient Problem   Codes FDA CDRH   C50854   Liver Laceration(s)                                                                           Laceration(s), liver
FDA   C54450   Patient Problem   Codes FDA CDRH   C50635   Loss of consciousness
FDA   C54450   Patient Problem   Codes FDA CDRH   C50636   Loss of pulse                                                                                 Pulse, Loss Of
FDA   C54450   Patient Problem   Codes FDA CDRH   C50641   Low Cardiac Output                                                                            Cardiac output, low|Output, low cardiac
FDA   C54450   Patient Problem   Codes FDA CDRH   C50644   Lung, Overinflation Of                                                                        Overinflation of lung
FDA   C54450   Patient Problem   Codes FDA CDRH   C27153   Lupus
FDA   C54450   Patient Problem   Codes FDA CDRH   C3832    Malaise
FDA   C54450   Patient Problem   Codes FDA CDRH   C50431   Mammogram, Abnormal                                                                      Abnormal mammogram
FDA   C54450   Patient Problem   Codes FDA CDRH   C50645   Mediastinal Shift                             Normal location of the mediastinum changes Shift, mediastinal
                                                                                                         to the right or left, depending upon the
                                                                                                         underlying cause.
FDA   C54450   Patient Problem   Codes FDA CDRH   C54027   Medical Problem                                                                          Patient Problem Code|Patient Problem
FDA   C54450   Patient Problem   Codes FDA CDRH   C2867    Memory Loss                                                                              Loss of memory
FDA   C54450   Patient Problem   Codes FDA CDRH   C26828   Meningitis
FDA   C54450   Patient Problem   Codes FDA CDRH   C35219   Menstrual Irregularities                      Deviations from the normal process; e.g.        Irregularities, menstrual
                                                                                                         delayed, difficult, profuse, scanty, unusual
                                                                                                         bleeding, etc.
FDA   C54450   Patient Problem Codes FDA CDRH     C50549   Microcysts, Epithelial                        Very small, round vesicles containing fluid     Epithelial microcysts
                                                                                                         and cellular debris observed on the surface
                                                                                                         of the cornea under slit-lamp examination in
                                                                                                         some types of corneal dystrophy and in
                                                                                                         wearers of extended-wear lenses.

FDA   C54450   Patient Problem Codes FDA CDRH     C50792   Micturation urgency                           A sudden compelling urge to urinate.            Urgency
FDA   C54450   Patient Problem Codes FDA CDRH     C34336   Miscarriage                                     Loss of the products of conception from the
                                                                                                           uterus before the fetus is viable;
                                                                                                           spontaneous abortion.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50432   Misdiagnosis
FDA   C54450   Patient Problem   Codes FDA CDRH   C50429   Missed Dose                                                                                        Dose, missed
FDA   C54450   Patient Problem   Codes FDA CDRH   C50888   Mitral Insufficiency                                                                               Insufficiency, mitral
FDA   C54450   Patient Problem   Codes FDA CDRH   C50653   Mitral Perforation                                                                                 Perforation, mitral
FDA   C54450   Patient Problem   Codes FDA CDRH   C50852   Mitral Regurgitation                            The backward flow of blood from the left           Regurgitation, mitral
                                                                                                           ventricle into the left atrium, owing to
                                                                                                           insufficiency of the mitral valve; it may be
                                                                                                           acute or chronic, usually due to mitral valve
                                                                                                           prolapse, rheumatic heart disease or a
                                                                                                           complication of cardiac dilatation.
FDA   C54450   Patient Problem Codes FDA CDRH     C50654   Mitral Stenosis                                 Narrowing of the left atrioventricular mitral      Stenosis, mitral
                                                                                                           orifice.
FDA   C54450   Patient Problem Codes FDA CDRH     C50655   Mitral Valve Prolapse                           Prolapse of the mitral valve, often with           Valve, prolapse of mitral|Prolapse, mitral valve
                                                                                                           regurgitation, associated with myxomatous
                                                                                                           proliferation of the leaflets of the mitral valve.

FDA   C54450   Patient Problem Codes FDA CDRH     C50825   Mitral Valve Replacement                                                                         Replacement, mitral valve|Valve replacement, mitral
FDA   C54450   Patient Problem Codes FDA CDRH     C50656   Muscle Spasm(s)                                 A sudden, violent, involuntary contraction of    Spasm(s), muscle)
                                                                                                           a muscle or group of muscles.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50657   Muscle Stimulation                                                                           Stimulation of muscle
FDA   C54450   Patient Problem   Codes FDA CDRH   C50658   Muscle Weakness                                                                              Weakness, muscular
FDA   C54450   Patient Problem   Codes FDA CDRH   C50659   Muscular Rigidity                               Stiffness or inflexibility.                  Rigidity, muscular
FDA   C54450   Patient Problem   Codes FDA CDRH   C50660   Muscular Tics                                   An involuntary, compulsive, repetitive
                                                                                                           stereotyped movement, usually of the face or
                                                                                                           shoulders.
FDA   C54450   Patient Problem Codes FDA CDRH     C27009   Myalgia
FDA   C54450   Patient Problem Codes FDA CDRH     C50661   Myocardial Contusion                            A bruise to the heart.                           Cardiac contusion|Contusion, cardiac|Contusion, myocardial
FDA   C54450   Patient Problem Codes FDA CDRH     C27996   Myocardial Infarction                           Gross necrosis of the myocardium, as a           Infarction (MI), myocardial|MI|Myocardial infarction, (MI)|MI, myocardial infarction
                                                                                                           result of interruption of the blood supply to
                                                                                                           the area, as in coronary thrombosis.
FDA   C54450   Patient Problem   Codes FDA CDRH   C34831   Myocarditis
FDA   C54450   Patient Problem   Codes FDA CDRH   C50662   Nasal Obstruction                                                                                Obstruction, nasal
FDA   C54450   Patient Problem   Codes FDA CDRH   C3258    Nausea
FDA   C54450   Patient Problem   Codes FDA CDRH   C16897   Necrosis
FDA   C54450   Patient Problem   Codes FDA CDRH   C50567   Necrosis Of Flap Tissue                                                                          Flap tissue, necrosis of|Tissue, necrosis of flap
FDA   C54450   Patient Problem   Codes FDA CDRH   C50665   Needle Stick/Puncture                                                                            Puncture/stick from needle|Stick/puncture from needle
FDA   C54450   Patient Problem   Codes FDA CDRH   C50666   Neonatal Deformities                                                                             Deformities, neonatal
FDA   C54450   Patient Problem   Codes FDA CDRH   C50667   Neonatal Hearing Impairment                                                                      Hearing impairment, neonatal|Impairment to hearing, neonatal
FDA   C54450   Patient Problem   Codes FDA CDRH   C50668   Neonatal Hearing Loss                                                                            Hearing loss, neonatal|Loss of hearing, neonatal
FDA   C54450   Patient Problem   Codes FDA CDRH   C16900   Neovascularization
FDA   C54450   Patient Problem   Codes FDA CDRH   C50669   Nerve Damage                                                                                     Damage to nerve(s)
FDA   C54450   Patient Problem   Codes FDA CDRH   C50915   Nerve Proximity NOS (Not Otherwise Specified)
FDA   C54450   Patient Problem   Codes FDA CDRH   C50787   Nerve Stimulation, Undesired                                                                     Undesired nerve stimulation|Stimulation of nerve, undesired
FDA   C54450   Patient Problem   Codes FDA CDRH   C50672   Neurological Deficit/Dysfunction                                                                 Deficit/dysfunction, neurological|Dysfunction/deficit, neurological
FDA   C54450   Patient Problem   Codes FDA CDRH   C4731    Neuropathy
FDA   C54450   Patient Problem   Codes FDA CDRH   C50673   Nipple Sensation, Changes In/Loss Of                                                             Changes in/loss of nipple sensation|Loss of/changes in nipple sensation|Sensation, changes in/loss of nipple
FDA   C54450   Patient Problem   Codes FDA CDRH   C50674   Nipple Ulceration                                                                                Ulceration, nipple
FDA   C54450   Patient Problem   Codes FDA CDRH   C50675   No Consequences Or Impact To Patient                                                             Consequences or impact to patient, none|Impact or consequences to patient, none|Patient, no consequences or impact to
FDA   C54450   Patient Problem   Codes FDA CDRH   C50912   No Patient Involvement
FDA   C54450   Patient Problem   Codes FDA CDRH   C50405   Nonpyrogenic
FDA   C54450   Patient Problem   Codes FDA CDRH   C34857   Numbness
FDA   C54450   Patient Problem   Codes FDA CDRH   C3284    Obstruction
FDA   C54450   Patient Problem   Codes FDA CDRH   C50678   Occlusion                                       The act of closure or the state of being
                                                                                                           closed; an obstruction; the relationship
                                                                                                           between all of the components of the
                                                                                                           masticatory system in normal function,
                                                                                                           dysfunction, and parafunction; momentary
                                                                                                           complete closure of some area in the vocal
                                                                                                           tract, causing stoppage of the breath and
                                                                                                           accumulation of pressure.

FDA   C54450   Patient Problem   Codes FDA CDRH   C50849   Optical Nerve Damage                                                                             Damage to optical nerve(s)|Nerve damage, optical
FDA   C54450   Patient Problem   Codes FDA CDRH   C50475   Optical tissue, breakdown of                                                                     Tissue, Breakdown Of Optical
FDA   C54450   Patient Problem   Codes FDA CDRH   C50679   Organ(s), Perforation Of                                                                         Perforation of organ(s)
FDA   C54450   Patient Problem   Codes FDA CDRH   C50680   Ossification                                    The formation of bone or of a bony
                                                                                                           substance; the conversion of fibrous tissue
                                                                                                           or of cartilage into bone or a bony
                                                                                                           substance.
FDA   C54450   Patient Problem Codes FDA CDRH     C50681   Osteolysis                                      Dissolution of bone; applied especially to the
                                                                                                           removal or loss of the calcium of bone.

FDA   C54450   Patient Problem   Codes FDA CDRH   C50910   Osteopenia                                                                                       Bone Loss
FDA   C54450   Patient Problem   Codes FDA CDRH   C50873   Overdose
FDA   C54450   Patient Problem   Codes FDA CDRH   C50850   Oversedated
FDA   C54450   Patient Problem   Codes FDA CDRH   C50683   Overstimulation
FDA   C54450   Patient Problem   Codes FDA CDRH   C50504   Overwear Syndrome                               Ocular pain which may be very intense,       Syndrome, overwear
                                                                                                           accompanied by corneal epithelium
                                                                                                           damage, conjunctival injection, lacrimation,
                                                                                                           blepharospasm, photophobia and hazy
                                                                                                           vision following corneal edema caused by
                                                                                                           overwear of contact lenses, principally the
                                                                                                           PMMA type.
FDA   C54450   Patient Problem Codes FDA CDRH     C50584   Oxygen Saturation, High                         The calculated measurements indicating the Saturation, high oxygen|High oxygen saturation
                                                                                                           degree to which oxygen is bound to
                                                                                                           hemoglobin is high.
FDA   C54450   Patient Problem Codes FDA CDRH     C50640   Oxygen Saturation, Low                          The calculated measurements indicating the Low oxygen saturation|Saturation, low oxygen
                                                                                                           degree to which oxygen is bound to
                                                                                                           hemoglobin is low.
FDA   C54450   Patient Problem   Codes FDA CDRH   C3303    Pain
FDA   C54450   Patient Problem   Codes FDA CDRH   C50605   Pain Relief, Inadequate                                                                          Inadequate pain relief
FDA   C54450   Patient Problem   Codes FDA CDRH   C26682   Pain, Abdominal                                                                                  Abdominal pain
FDA   C54450   Patient Problem   Codes FDA CDRH   C50663   Pain, Neck                                                                                       Neck pain
FDA   C54450   Patient Problem   Codes FDA CDRH   C50685   Pallor
FDA   C54450   Patient Problem   Codes FDA CDRH   C37999   Palpitations
FDA   C54450   Patient Problem   Codes FDA CDRH   C50686   Pannus Formation                                Superficial vascularization of the cornea with Formation, pannus
                                                                                                           infiltration of granulation tissue; an
                                                                                                           inflammatory exudate overlying the lining
                                                                                                           layer of synovial cells on the inside of a joint.

FDA   C54450   Patient Problem Codes FDA CDRH     C3310    Paralysis
FDA   C54450   Patient Problem Codes FDA CDRH     C50687   Paraplegia                                      Paralysis of the legs and lower part of the
                                                                                                           body.
FDA   C54450   Patient Problem Codes FDA CDRH     C50688   Paresis                                         A slight or incomplete paralysis.
FDA   C54450   Patient Problem Codes FDA CDRH     C61389   Patch test, abnormal results of
FDA   C54450   Patient Problem Codes FDA CDRH     C50525   Peak Expiratory Flowrate, Decreased             A decrease of the greatest rate of flow that     Flowrate, decreased peak expiratory|Decreased peak expiratory flowrate
                                                                                                           can be achieved during forced expiration
                                                                                                           beginning with the lungs fully inflated.

FDA   C54450   Patient Problem Codes FDA CDRH     C50610   Peak Expiratory Flowrate, Increased             An increase of the greatest rate of flow that    Flowrate, increased peak expiratory|Increased peak expiratory flowrate
                                                                                                           can be achieved during forced expiration
                                                                                                           beginning with the lungs fully inflated.

FDA   C54450   Patient Problem Codes FDA CDRH     C50691   Peeling                                         A peeling off or loss of epidermis, as in
                                                                                                           sunburn, postscarlatinal peeling, or toxic
                                                                                                           epidermal necrolysis.
FDA   C54450   Patient Problem Codes FDA CDRH     C3889    Pelvic Inflammatory Disease                     Any pelvic infection involving the upper         Disease (PID), pelvic inflammatory|Pelvic inflammatory disease, (PID)|Inflammatory disease (PID), pelvic|PID|PID, pelvic inflammatory diseasec
                                                                                                           female genital tract beyond the cervix.
FDA   C54450   Patient Problem Codes FDA CDRH     C4080    Perforation
FDA   C54450   Patient Problem Codes FDA CDRH     C73501   Perinatal Brain Injury                          Injury occurring as a result of the delivery
                                                                                                           process.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50694   Peripheral Vascular Disease                                                                      Disease, peripheral vascular|Vascular disease, peripheral
FDA   C54450   Patient Problem   Codes FDA CDRH   C50695   Peritoneal Laceration(s)                                                                         Laceration(s), peritoneal
FDA   C54450   Patient Problem   Codes FDA CDRH   C26849   Peritonitis
FDA   C54450   Patient Problem   Codes FDA CDRH   C27061   Peroneal Nerve Palsy                            Paralysis of the nerves located in the legs.     Nerve palsy, peroneal|Palsy, peroneal nerve
FDA   C54450   Patient Problem Codes FDA CDRH     C26851   Pharyngitis
FDA   C54450   Patient Problem Codes FDA CDRH     C38003   Phlebitis
FDA   C54450   Patient Problem Codes FDA CDRH     C50697   Phosphene Visualization                     An objective visual sensation that appears Visualization, phosphene
                                                                                                       with the eyes closed and in the absence of
                                                                                                       visual light.
FDA   C54450   Patient Problem Codes FDA CDRH     C50698   Phototoxicity                               A nonimmunologic, chemically induced type
                                                                                                       of photosensitivity.
FDA   C54450   Patient Problem   Codes FDA CDRH   C17000   Pleomorphism
FDA   C54450   Patient Problem   Codes FDA CDRH   C3331    Pleural Effusion                                                                           Effusion, pleural
FDA   C54450   Patient Problem   Codes FDA CDRH   C3333    Pneumonia
FDA   C54450   Patient Problem   Codes FDA CDRH   C38006   Pneumothorax
FDA   C54450   Patient Problem   Codes FDA CDRH   C50699   Pocket Erosion                              Erosion of patient's skin pocket which       Erosion, pocket
                                                                                                       houses a device.
FDA   C54450   Patient Problem Codes FDA CDRH     C50700   Polydipsia                                  Chronic excessive intake of water; it may be
                                                                                                       from an organic cause, such as the
                                                                                                       dehydration of diabetes mellitus, diabetes
                                                                                                       insipidus, or a reaction to medication, or
                                                                                                       from a psychological cause. When untreated
                                                                                                       it can lead to water intoxication.

FDA   C54450   Patient Problem Codes FDA CDRH     C26925   Polymyositis
FDA   C54450   Patient Problem Codes FDA CDRH     C50701   Positive antinuclear antibodies (ANA)       Antibodies directed against nuclear           ANA, positive antinuclear antibodies|Antinuclear antibodies (ANA), positive|Antibodies (ANA), positive antinuclear
                                                                                                       antigens; almost invariably found in systemic
                                                                                                       lupus erythematosus and are frequently
                                                                                                       found in rheumatoid arthritis, scleroderma,
                                                                                                       Sjogren's Syndrome and mixed connective
                                                                                                       tissue disease.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50706   Pressure Sores/Ulcers                       Death of tissue due to external pressure.     Pressure, necrosis|Ulcers/sores, pressure|Sores/ulcers, pressure|Necrosis, Pressure
FDA   C54450   Patient Problem   Codes FDA CDRH   C36173   Prolapse
FDA   C54450   Patient Problem   Codes FDA CDRH   C50711   Pseudoaneurysm
FDA   C54450   Patient Problem   Codes FDA CDRH   C27298   Ptosis
FDA   C54450   Patient Problem   Codes FDA CDRH   C50585   Pulmonary Arterial Wedge Pressure, High     The measurement of the mean left arterial     Arterial wedge pressure, high pulmonary|Pressure, high pulmonary arterial wedge|High pulmonary arterial wedge pressure|Wedge pressure, high pulmonary arterial
                                                                                                       pressure, as measured by a catheter
                                                                                                       introduced into the distal pulmonary artery,
                                                                                                       is high.
FDA   C54450   Patient Problem Codes FDA CDRH     C50642   Pulmonary Arterial Wedge Pressure, Low      The measurement of the mean left              Arterial wedge pressure, low pulmonary|Pressure, low pulmonary arterial wedge|Wedge pressure, low pulmonary arterial|Low pulmonary arterial wedge pressure
                                                                                                       pulmonary arterial pressure, as measured by
                                                                                                       a catheter introduced into the distal
                                                                                                       pulmonary artery, is low.
FDA   C54450   Patient Problem Codes FDA CDRH     C50677   Pulmonary Arterial Wedge Pressure, Normal   The measurement of the mean left arterial     Arterial wedge pressure, normal pulmonary|Wedge pressure, normal pulmonary arterial|Pressure, normal pulmonary arterial wedge|Normal pulmonary arterial wedge pressure
                                                                                                       pressure, as measured by a catheter
                                                                                                       introduced into the distal pulmonary artery,
                                                                                                       is normal.
FDA   C54450   Patient Problem Codes FDA CDRH     C50712   Pulmonary Dysfunction                                                                     Dysfunction, pulmonary
FDA   C54450   Patient Problem Codes FDA CDRH     C26868   Pulmonary Edema                                                                           Edema, pulmonary
FDA   C54450   Patient Problem Codes FDA CDRH     C50713   Pulmonary Embolism                          The closure of the pulmonary artery or one of Embolism, pulmonary
                                                                                                       its branches by an embolus, sometimes
                                                                                                       associated with infarction of the lung.

FDA   C54450   Patient Problem Codes FDA CDRH     C50714   Pulmonary Infarction                        Localized necrosis of lung tissue caused by Infarction, pulmonary
                                                                                                       obstruction of the arterial blood supply, most
                                                                                                       often due to pulmonary embolism.

FDA   C54450   Patient Problem Codes FDA CDRH     C51447   Pulmonary Insufficiency                                                                    Insufficiency, pulmonary
FDA   C54450   Patient Problem Codes FDA CDRH     C50848   Pulmonary Regurgitation                     The backflow of blood from the pulmonary       Regurgitation, pulmonary
                                                                                                       artery into the right ventricle, owing to
                                                                                                       insufficiency of the pulmonic semilunar
                                                                                                       valve.
FDA   C54450   Patient Problem Codes FDA CDRH     C50715   Pulmonary Stenosis                          Narrowing of the opening between the           Stenosis, pulmonary
                                                                                                       pulmonary artery and the right ventricle,
                                                                                                       usually at the level of the valve leaflets.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50817   Pulmonary Valve Replacement                                                                Replacement of pulmonary valve|Valve, replacement of pulmonary
FDA   C54450   Patient Problem   Codes FDA CDRH   C50533   Pulse pressure, diminished                                                                 Pulse, Diminished|Pulse, diminished
FDA   C54450   Patient Problem   Codes FDA CDRH   C50622   Pulse, Irregular                            A pulse that beats at irregular intervals.     Irregular pulse
FDA   C54450   Patient Problem   Codes FDA CDRH   C50716   Pupillary Block                             An obstruction of the pupil.                   Block, pupillary
FDA   C54450   Patient Problem   Codes FDA CDRH   C50717   Purulent discharge                          Consisting of or containing pus; associated    Discharge, purulent
                                                                                                       with the formation of or caused by pus.

FDA   C54450   Patient Problem Codes FDA CDRH     C50721   Quadriplegia                                Paralysis of all four limbs.
FDA   C54450   Patient Problem Codes FDA CDRH     C61395   R on T phenomenon                           The occurrence of a premature ventricular
                                                                                                       complex near the peak of the T wave in
                                                                                                       electrocardiography; it may lead to
                                                                                                       ventricular tachycardia or fibrillation.
FDA   C54450   Patient Problem Codes FDA CDRH     C50722   Radiation burn                              A burn caused by exposure to x-ray, radium, Burn, Radiation
                                                                                                       sunlight, atomic or any other type of radiant
                                                                                                       energy.
FDA   C54450   Patient Problem   Codes FDA CDRH   C61401   Radiation Exposure, Unintended
FDA   C54450   Patient Problem   Codes FDA CDRH   C50862   Radiation Overdose                                                                         Overdose of radiation
FDA   C54450   Patient Problem   Codes FDA CDRH   C50723   Radiation Sickness Syndrome                 Radiation induced skin desquamation            Sickness syndrome, radiation|Syndrome, radiation sickness
FDA   C54450   Patient Problem   Codes FDA CDRH   C52354   Radiation Underdose                                                                        Underdose, radiation
FDA   C54450   Patient Problem   Codes FDA CDRH   C3349    Radiodermatitis                             A cutaneous inflammatory reaction occurring
                                                                                                       as a result of exposure to biologically
                                                                                                       effective levels of ionizing radiation.

FDA   C54450   Patient Problem Codes FDA CDRH     C50637   Range Of Motion, Loss Of                                                                   Motion, loss of range of|Loss of range of motion
FDA   C54450   Patient Problem Codes FDA CDRH     C39594   Rash
FDA   C54450   Patient Problem Codes FDA CDRH     C50724   Raynauds Phenomenon                         Intermittent bilateral attacks of ischemia of Phenomenon, Raynauds
                                                                                                       the fingers or toes and sometimes of the
                                                                                                       ears or nose, marked by severe pallor, and
                                                                                                       often accompanied by paresthesia and pain.

FDA   C54450   Patient Problem   Codes FDA CDRH   C25637   Reaction
FDA   C54450   Patient Problem   Codes FDA CDRH   C3508    Reaction, Injection Site                                                                   Injection site reaction
FDA   C54450   Patient Problem   Codes FDA CDRH   C50419   Reaction, Local                                                                            Local reaction
FDA   C54450   Patient Problem   Codes FDA CDRH   C50725   Red Eye(s)                                  Lay term applied to any condition with         Eye(s), red
                                                                                                       dilation of conjunctival or ciliary blood
                                                                                                       vessels; innumerable causes, especially
                                                                                                       irritation and infection.
FDA   C54450   Patient Problem Codes FDA CDRH     C50726   Regurgitation                               Flow in the opposite direction from normal,
                                                                                                       as the casting up of undigested food or gas
                                                                                                       from the stomach, or the backward flowing of
                                                                                                       blood into the heart, or between the
                                                                                                       chambers of the heart when a valve is
                                                                                                       incompetent.
FDA   C54450   Patient Problem Codes FDA CDRH     C50797   Regurgitation, Valvular                     Regurgitation of the blood of the heart valves Valvular regurgitation
                                                                                                       owning to imperfect closing, insufficiency or
                                                                                                       incompetency of the valves.

FDA   C54450   Patient Problem   Codes FDA CDRH   C50820   Reinfusion
FDA   C54450   Patient Problem   Codes FDA CDRH   C50828   Reintubate
FDA   C54450   Patient Problem   Codes FDA CDRH   C9439    Renal Disease, End Stage                    Chronic, irreversible renal failure.           Disease (ESRD), end stage renal|Renal disease (ESRD), end stage|End stage renal disease (ESRD)|ESRD, end stage renal disease|ESRD
FDA   C54450   Patient Problem   Codes FDA CDRH   C4376    Renal failure                                                                              Failure, renal
FDA   C54450   Patient Problem   Codes FDA CDRH   C50727   Reocclusion
FDA   C54450   Patient Problem   Codes FDA CDRH   C50728   Respiratory Acidosis                        A state due to excess retention of carbon   Acidosis, Respiratory
                                                                                                       dioxide in the body.
FDA   C54450   Patient Problem Codes FDA CDRH     C50729   Respiratory Alkalosis                       A pathologic condition resulting from
                                                                                                       accumulation of base, or from loss of acid
                                                                                                       without comparable loss of base in the body
                                                                                                       fluids, and characterized by decrease in
                                                                                                       hydrogen ion concentration.
FDA   C54450   Patient Problem Codes FDA CDRH     C27165   Respiratory Distress                                                                    Distress, respiratory
FDA   C54450   Patient Problem Codes FDA CDRH     C27560   Respiratory Distress Syndrome Of Newborns   A condition of the newborn marked by        RDS, respiratory distress syndrome of newborns|Respiratory distress syndrome of newborns (RDS)|Syndrome of newborns (RDS), respiratory distress|RDS Of Newborns|Newborns (RDS), respiratory distress syndrome of
                                                                                                       dyspnea with cyanosis, most frequently
                                                                                                       occurring in premature infants, children of
                                                                                                       diabetic mothers and infants delivered by
                                                                                                       cesarean section, and sometimes with no
                                                                                                       predisposing cause.
FDA   C54450   Patient Problem Codes FDA CDRH     C26872   Respiratory failure                                                                     Failure, respiratory
FDA   C54450   Patient Problem   Codes FDA CDRH   C50474   Respiratory Rate, Decreased                                                           Decreased respiratory rate|Rate of respiration, decreased
FDA   C54450   Patient Problem   Codes FDA CDRH   C50767   Respiratory Rate, Increased                                                           Increased respiratory rate|Rate of respiration, increased
FDA   C54450   Patient Problem   Codes FDA CDRH   C50822   Resuscitation
FDA   C54450   Patient Problem   Codes FDA CDRH   C50731   Retina, Damage To                                                                     Damage to retina
FDA   C54450   Patient Problem   Codes FDA CDRH   C34979   Retina, Degeneration Of                                                               Degeneration of retina
FDA   C54450   Patient Problem   Codes FDA CDRH   C50732   Retina, Tear(s) In
FDA   C54450   Patient Problem   Codes FDA CDRH   C34882   Rheumatic Heart Disease                                                          Disease, rheumatic heart|Heart disease, rheumatic
FDA   C54450   Patient Problem   Codes FDA CDRH   C50733   Right Ventricular Dysfunction                                                    Dysfunction, right ventricular
FDA   C54450   Patient Problem   Codes FDA CDRH   C50846   Right Ventricular Failure            Failure of proper functioning of the right  Failure, right ventricular|Ventricular failure, right
                                                                                                ventricle, with venous engorgement, hepatic
                                                                                                enlargement, and subcutaneous edema.

FDA   C54450   Patient Problem Codes FDA CDRH     C50734   Right Ventricular Hypertrophy        Enlargement or overgrowth of the                 Hypertrophy, right ventricular|Ventricular hypertrophy, right
                                                                                                myocardium of the right ventricle, due
                                                                                                chronic pressure overload.
FDA   C54450   Patient Problem Codes FDA CDRH     C9445    Rupture
FDA   C54450   Patient Problem Codes FDA CDRH     C50827   Scar Excision                                                                         Excision, scar
FDA   C54450   Patient Problem Codes FDA CDRH     C50737   Scar Tissue                          Formation of new tissue formed in the            Cicatrix|Tissue, scar
                                                                                                healing of a wound.
FDA   C54450   Patient Problem   Codes FDA CDRH   C34483   Scarring
FDA   C54450   Patient Problem   Codes FDA CDRH   C26746   Scleroderma
FDA   C54450   Patient Problem   Codes FDA CDRH   C21097   Sedation
FDA   C54450   Patient Problem   Codes FDA CDRH   C2962    Seizures                                                                              Convulsion
FDA   C54450   Patient Problem   Codes FDA CDRH   C50436   Seizures, Absence                    The seizure seen in absence epilepsy,            Seizures, Petit-Mal|Petit-mal seizures
                                                                                                consisting of a sudden momentary break in
                                                                                                consciousness of thought or activity, often
                                                                                                accompanied by automatisms or clonic
                                                                                                movements, especially of the eyelids.

FDA   C54450   Patient Problem Codes FDA CDRH     C50689   Seizures, Focal                      Partial seizure.                              Focal seizuresl
FDA   C54450   Patient Problem Codes FDA CDRH     C50847   Seizures, Focal Motor                A simple partial seizure consisting of clonus Focal motor seizures
                                                                                                or spasm of a muscle or muscle group; it
                                                                                                may be single or in a continuous and
                                                                                                repetitive series or may spread to adjacent
                                                                                                muscles.
FDA   C54450   Patient Problem Codes FDA CDRH     C50574   Seizures, Grand-Mal                  A symptomatic form of epilepsy often          Grand-mal seizures
                                                                                                preceded by an aura; characterized by loss
                                                                                                of consciousness with generalized tonic-
                                                                                                clonic seizures.
FDA   C54450   Patient Problem Codes FDA CDRH     C3364    Sepsis
FDA   C54450   Patient Problem Codes FDA CDRH     C50739   Seroma                               A tumor-like collection of serum in the
                                                                                                tissues.
FDA   C54450   Patient Problem   Codes FDA CDRH   C38038   Shaking/Tremors                                                                       Tremors/shaking
FDA   C54450   Patient Problem   Codes FDA CDRH   C35016   Shock
FDA   C54450   Patient Problem   Codes FDA CDRH   C50452   Shock, Acoustic                                                                       Acoustic Shock
FDA   C54450   Patient Problem   Codes FDA CDRH   C50460   Shock, Anaphylactic                  Systemic anaphylaxis is the most dramatic        Anaphylaxis|Anaphylactic shock
                                                                                                example of an immediate hypersensitivity
                                                                                                reaction; is uncommon and unexpected in
                                                                                                nature and occasionally results in a fatal
                                                                                                outcome.
FDA   C54450   Patient Problem Codes FDA CDRH     C50482   Shock, Cardiogenic                   Shock resulting from primary failure of the      Cardiogenic shock
                                                                                                heart in its pumping function, as in
                                                                                                myocardial infarction, severe
                                                                                                cardiomyopathy, or mechanical obstruction
                                                                                                or compression of the heart.
FDA   C54450   Patient Problem Codes FDA CDRH     C50596   Shock, Hypovolemic                   Shock resulting from insufficient blood          Hypovolemic shock
                                                                                                volume for the maintenance of adequate
                                                                                                cardiac output, blood pressure and tissue
                                                                                                perfusion.
FDA   C54450   Patient Problem Codes FDA CDRH     C50615   Shock, Insulin                       A hypoglycemic reaction to overdosage of         Insulin shock
                                                                                                insulin, a skipped meal, or strenuous
                                                                                                exercise in an insulin-dependent diabetic.
FDA   C54450   Patient Problem Codes FDA CDRH     C50671   Shock, Neurogenic                    Shock resulting from neurogenic                  Neurogenic shock
                                                                                                vasodilation, which can be produced by
                                                                                                cerebral trauma or hemorrhage, spinal cord
                                                                                                injury, deep general or spinal anesthesia, or
                                                                                                toxic central nervous system depression.

FDA   C54450   Patient Problem Codes FDA CDRH     C50703   Shock, Postoperative                 A state of shock following a surgical            Postoperative shock
                                                                                                operation.
FDA   C54450   Patient Problem   Codes FDA CDRH   C35018   Shock, septic                                                                         Septic shock
FDA   C54450   Patient Problem   Codes FDA CDRH   C35019   Shock, Surgical                                                                       Surgical shock
FDA   C54450   Patient Problem   Codes FDA CDRH   C50782   Shock, Traumatic                     Any shock produced by trauma.                    Traumatic shock
FDA   C54450   Patient Problem   Codes FDA CDRH   C50741   Sinus, Perforation Of                                                                 Perforation of sinus
FDA   C54450   Patient Problem   Codes FDA CDRH   C26883   Sjogren's Syndrome                                                                    Syndrome, sjogren's
FDA   C54450   Patient Problem   Codes FDA CDRH   C3327    Skin Discoloration                                                                    Discoloration of skin
FDA   C54450   Patient Problem   Codes FDA CDRH   C50845   Skin Erosion                         A gradual breakdown or very shallow              Erosion, skin
                                                                                                ulceration of the skin which involves only the
                                                                                                epidermis and heals without scarring.
FDA   C54450   Patient Problem   Codes FDA CDRH   C2983    Skin Inflammation                                                                     Inflammation of skin
FDA   C54450   Patient Problem   Codes FDA CDRH   C50743   Skin Irritation                                                                       Irritation of skin
FDA   C54450   Patient Problem   Codes FDA CDRH   C50744   Skin Tears
FDA   C54450   Patient Problem   Codes FDA CDRH   C3376    Sleep Disturbances                                                                    Disturbances, sleep
FDA   C54450   Patient Problem   Codes FDA CDRH   C50746   Sneezing
FDA   C54450   Patient Problem   Codes FDA CDRH   C50747   Sore Throat                                                                           Throat, sore
FDA   C54450   Patient Problem   Codes FDA CDRH   C50750   Spinal Cord Injury                                                                    Injury, spinal cord
FDA   C54450   Patient Problem   Codes FDA CDRH   C50751   Spinal Injury                                                                         Injury, spinal
FDA   C54450   Patient Problem   Codes FDA CDRH   C35035   Sprain
FDA   C54450   Patient Problem   Codes FDA CDRH   C41330   ST Segment Depression                                                               Depression, ST segment
FDA   C54450   Patient Problem   Codes FDA CDRH   C50540   ST Segment Elevation                 Evaluation of the interval from the end of     Elevation, ST segment
                                                                                                ventricular depolarization to the onset of the
                                                                                                T wave; it is usually isoelectric in normal
                                                                                                subjects.
FDA   C54450   Patient Problem Codes FDA CDRH     C50752   Stacking Breaths                     Condition where there are a greater number Breaths, stacking
                                                                                                of inhalations relative to the number of
                                                                                                exhalations.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50921   Staphylococcus Aureus                                                               S. aureus
FDA   C54450   Patient Problem   Codes FDA CDRH   C50754   Stenosis                             Narrowing or stricture of a duct or canal.     Stricture
FDA   C54450   Patient Problem   Codes FDA CDRH   C50664   Stiffness, Neck                                                                     Neck stiffness
FDA   C54450   Patient Problem   Codes FDA CDRH   C50756   Strangulation                        Chocking or arrest of respiration due to
                                                                                                occlusion of the air passageway; arrest of
                                                                                                circulation in a part due to compression.
FDA   C54450   Patient Problem Codes FDA CDRH     C50760   Subepithelial Infiltration                                                          Infiltration, subepithelial
FDA   C54450   Patient Problem Codes FDA CDRH     C50911   Sudden Cardiac Death                                                                Cardiac death, sudden|Death, sudden cardiac
FDA   C54450   Patient Problem Codes FDA CDRH     C50762   Suffocation                          The stopping of respiration or the asphyxia
                                                                                                that results from it.
FDA   C54450   Patient Problem Codes FDA CDRH     C50763   Sunset Syndrome                      Decentration, or malposition of intraocular    Syndrome, sunset
                                                                                                lens; zonular dehiscence or lens malposition
                                                                                                caused by zonular or parsplana fixation.

FDA   C54450   Patient Problem   Codes FDA CDRH   C50823   Surgery, Prolonged                                                                    Prolonged surgery
FDA   C54450   Patient Problem   Codes FDA CDRH   C15329   Surgical Procedure                                                                    Procedure, surgical
FDA   C54450   Patient Problem   Codes FDA CDRH   C50421   Surgical Procedure Aborted/Stopped                                                    Procedure aborted/stopped, surgical
FDA   C54450   Patient Problem   Codes FDA CDRH   C50831   Surgical Procedure, Additional                                                        Procedure, additional surgical
FDA   C54450   Patient Problem   Codes FDA CDRH   C50422   Surgical Procedure, Delayed                                                           Procedure, delayed surgical
FDA   C54450   Patient Problem   Codes FDA CDRH   C50830   Surgical Procedure, Repeated                                                          Procedure repeated, surgical|Surgical procedure, repeated
FDA   C54450   Patient Problem   Codes FDA CDRH   C50833   Surgical Procedure, Unnecessary                                                       Procedure, unnecessary surgical
FDA   C54450   Patient Problem   Codes FDA CDRH   C50868   Suture Abrasion
FDA   C54450   Patient Problem   Codes FDA CDRH   C36172   Sweating
FDA   C54450   Patient Problem   Codes FDA CDRH   C3399    Swelling
FDA   C54450   Patient Problem   Codes FDA CDRH   C50764   Swollen Glands                                                                        Glands, swollen
FDA   C54450   Patient Problem   Codes FDA CDRH   C50765   Swollen Lymph Nodes                                                                   Lymph nodes, swollen|Nodes, swollen lymph
FDA   C54450   Patient Problem   Codes FDA CDRH   C35053   Syncope                                                                               Faint
FDA   C54450   Patient Problem   Codes FDA CDRH   C50766   Synovitis                            Inflammation of a synovial membrane.
FDA   C54450   Patient Problem   Codes FDA CDRH   C38029   Tachycardia                                                                           Heart Rate, Increased|Increased heart rate
FDA   C54450   Patient Problem   Codes FDA CDRH   C50552   Tearing, Excessive                                                                    Excessive tearing
FDA   C54450   Patient Problem   Codes FDA CDRH   C50778   Teeth, Sensitivity Of                                                                 Sensitivity Of Tooth
FDA   C54450   Patient Problem Codes FDA CDRH     C50844   Tentorial Tears                                  Pertaining to tears involving the tentorium of      Tears, tentorial
                                                                                                            the cerebellum.
FDA   C54450   Patient Problem   Codes FDA CDRH   C50916   Teratogenic Effects                                                                                  Effects, teratogenic
FDA   C54450   Patient Problem   Codes FDA CDRH   C50789   Therapeutic Effects, Unexpected                                                                      Effects, unexpected therapeutic|Unexpected therapeutic effects
FDA   C54450   Patient Problem   Codes FDA CDRH   C50526   Therapeutic Response, Decreased                                                                      Decreased therapeutic response|Response, decreased therapeutic
FDA   C54450   Patient Problem   Codes FDA CDRH   C50611   Therapeutic Response, Increased                                                                      Response, increased therapeutic|Increased therapeutic response
FDA   C54450   Patient Problem   Codes FDA CDRH   C50423   Therapy/Non-Surgical Treatment, Aborted/Stopped                                                      Treatment (non-surgical)/therapy, aborted/stopped|Non-surgical treatment/therapy, aborted/stopped
FDA   C54450   Patient Problem   Codes FDA CDRH   C50424   Therapy/Non-Surgical Treatment, Additional                                                           Non-surgical treatment/therapy, additional
FDA   C54450   Patient Problem   Codes FDA CDRH   C50425   Therapy/Non-Surgical Treatment/Delayed/Prolonged                                                     Treatment (non-surgical)/therapy, delayed|Therapy/non-surgical treatment, delayed|Non-surgical treatment/therapy, delayed
FDA   C54450   Patient Problem   Codes FDA CDRH   C28195   Thromboembolism
FDA   C54450   Patient Problem   Codes FDA CDRH   C26891   Thrombosis
FDA   C54450   Patient Problem   Codes FDA CDRH   C27083   Thrombus                                         An aggregation of blood factors, primarily
                                                                                                            platelets and fibrin with entrapment of
                                                                                                            cellular elements, frequently causing
                                                                                                            vascular obstruction at the point of its
                                                                                                            formation.
FDA   C54450   Patient Problem Codes FDA CDRH     C50770   Thyroid Problems                                                                                     Problems, thyroid
FDA   C54450   Patient Problem Codes FDA CDRH     C50771   Tingling                                         A sensation as of repetitive pin pricks,
                                                                                                            caused by cold or by striking a nerve, or as a
                                                                                                            result of various diseases of the central or
                                                                                                            peripheral nervous system.
FDA   C54450   Patient Problem Codes FDA CDRH     C50772   Tinnitus                                         A noise in the ears, such as ringing,               Ears, ringing in|Ringing in ears
                                                                                                            buzzing, roaring, clicking.
FDA   C54450   Patient Problem Codes FDA CDRH     C61375   Tissue Breakdown
FDA   C54450   Patient Problem Codes FDA CDRH     C50773   Tissue Damage                                                                                        Damage, tissue
FDA   C54450   Patient Problem Codes FDA CDRH     C50779   Torsades-De-Pointes                              'Fringe of pointed tips'; An atypical rapid
                                                                                                            ventricular tachycardia with periodic waxing
                                                                                                            and waning of amplitude of the QRS
                                                                                                            complexes on the electrogram as well as
                                                                                                            rotation of the complexes about the
                                                                                                            isoelectric line.
FDA   C54450   Patient Problem Codes FDA CDRH     C50780   Toxemia                                          The condition resulting from the spread of
                                                                                                            bacterial products (toxins) by the
                                                                                                            bloodstream.
FDA   C54450   Patient Problem Codes FDA CDRH     C35498   Toxic Shock Syndrome                             A severe illness caused by infection with           Shock syndrome (TSS), toxic|TSS|TSS, toxic shock syndrome|Toxic shock syndrome, (TSS)|Syndrome (TSS), toxic shock
                                                                                                            staphylococcus aureus and characterized by
                                                                                                            high fever of sudden onset, vomiting,
                                                                                                            diarrhea, and myalgia, followed by
                                                                                                            hypotension and in severe cases, shock; a
                                                                                                            sunburn-like rash with peeling of the skin,
                                                                                                            especially of the palms and soles, occurs
                                                                                                            during the acute phase.
FDA   C54450   Patient Problem Codes FDA CDRH     C27990   Toxicity
FDA   C54450   Patient Problem Codes FDA CDRH     C50493   Toxins In Children                               Children affected by toxins may be due to           Children, toxins in
                                                                                                            silicone breast implants and their effects on
                                                                                                            unborn children and from breastfeeding.

FDA   C54450   Patient Problem   Codes FDA CDRH   C50454   Toxoplasmosis, Acquired                            Acquired as an adult.                             Acquired toxoplasmosis
FDA   C54450   Patient Problem   Codes FDA CDRH   C50503   Toxoplasmosis, Congenital                          Passed from mother to fetus.                      Congenital toxoplasmosis
FDA   C54450   Patient Problem   Codes FDA CDRH   C15341   Tracheostomy
FDA   C54450   Patient Problem   Codes FDA CDRH   C15192   Transfusion Of Blood Products                                                                       Blood products, transfusion of
FDA   C54450   Patient Problem   Codes FDA CDRH   C50832   Transfusion with incompatible blood                                                                 Blood, transfusion with incompatible|Incompatible blood, transfusion with
FDA   C54450   Patient Problem   Codes FDA CDRH   C50781   Transient Ischemic Attack                          A brief attack (from a few minutes to an         Attack, transient ischemic|Ischemic attack, transient
                                                                                                              hour) of cerebral dysfunction of vascular
                                                                                                              origin, with no persistent neurological deficit.

FDA   C54450   Patient Problem Codes FDA CDRH     C50920   Transplant Of Organ/Tissue                                                                         Organ/tissue transplant|Tissue/organ transplant
FDA   C54450   Patient Problem Codes FDA CDRH     C15986   Treatment With Medication(s)                                                                       Medication(s), treatment with
FDA   C54450   Patient Problem Codes FDA CDRH     C50842   Tricuspid Insufficiency                            Incomplete closure of the tricuspid valve,      Insufficiency, tricuspid
                                                                                                              resulting in tricuspid regurgitation; it is
                                                                                                              usually secondary to systolic overload in the
                                                                                                              right ventricle.
FDA   C54450   Patient Problem Codes FDA CDRH     C50843   Tricuspid Regurgitation                            The backflow of blood from the right ventricle Regurgitation, tricuspid
                                                                                                              into the right atrium, owning to imperfect
                                                                                                              functioning/insufficiency of the tricuspid
                                                                                                              valve.
FDA   C54450   Patient Problem Codes FDA CDRH     C50783   Tricuspid Stenosis                                 Narrowing or stricture of the tricuspid orifice Stenosis, tricuspid
                                                                                                              of the heart.
FDA   C54450   Patient Problem Codes FDA CDRH     C50816   Tricuspid Valve Replacement                                                                        Replacement of tricuspid valve|Valve, replacement of tricuspid
FDA   C54450   Patient Problem Codes FDA CDRH     C50784   Twiddlers Syndrome                                 Dislodgement, breakdown, or other               Syndrome, twiddler's
                                                                                                              malfunction of an artificial cardiac
                                                                                                              pacemaker, chemotherapy port, drip infusion
                                                                                                              valve, or similar implanted diagnostic or
                                                                                                              therapeutic device as a result of
                                                                                                              unconscious or habitual manipulation by the
                                                                                                              patient.
FDA   C54450   Patient Problem Codes FDA CDRH     C50785   Twitching                                          The occurrence of a single contraction or a
                                                                                                              series of contractions of a muscle.
FDA   C54450   Patient Problem Codes FDA CDRH     C50794   UGH (Uveitis-Glaucoma-Hyphema) Syndrome            For complications that occur secondary to       Syndrome, uveitis-glaucoma-hyphema (UGH)|Uveitis-glaucoma-hyphema (UGH) syndrome
                                                                                                              intraocular lens implantation in the anterior
                                                                                                              chamber; caused by rubbing of the lens loop
                                                                                                              (haptics).
FDA   C54450   Patient Problem   Codes FDA CDRH   C3426    Ulcer
FDA   C54450   Patient Problem   Codes FDA CDRH   C25757   Ulceration
FDA   C54450   Patient Problem   Codes FDA CDRH   C50407   Under No Medication                                                                                  Medication, not under
FDA   C54450   Patient Problem   Codes FDA CDRH   C50408   Under No Sedation                                                                                    Sedation, not under
FDA   C54450   Patient Problem   Codes FDA CDRH   C17998   Unknown                                                                                              Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known)
FDA   C54450   Patient Problem   Codes FDA CDRH   C34851   Uremia
FDA   C54450   Patient Problem   Codes FDA CDRH   C26906   Urinary Frequency                                                                                    Frequency, urinary
FDA   C54450   Patient Problem   Codes FDA CDRH   C50790   Urinary Retention                                  Accumulation of urine within the bladder          Retention, urinary
                                                                                                              because of the inability to urinate.
FDA   C54450   Patient Problem   Codes FDA CDRH   C3432    Urticaria                                          Urticaria.                                        Hives
FDA   C54450   Patient Problem   Codes FDA CDRH   C50793   Uterine Perforation                                                                                  Perforation of uterus
FDA   C54450   Patient Problem   Codes FDA CDRH   C26909   Uveitis
FDA   C54450   Patient Problem   Codes FDA CDRH   C50795   Vaginal Discharge                                                                                    Discharge, vaginal
FDA   C54450   Patient Problem   Codes FDA CDRH   C50522   Vaginal Mucosa Damage                                                                                Mucosa damage, vaginal|Damage, vaginal mucosa
FDA   C54450   Patient Problem   Codes FDA CDRH   C50600   Vascular system (circulation), impaired                                                              Circulation, impaired|Impaired circulation
FDA   C54450   Patient Problem   Codes FDA CDRH   C40866   Vasoconstriction                                                                                     Vasospasm
FDA   C54450   Patient Problem   Codes FDA CDRH   C40867   Vasodilatation                                     A state of increased caliber of the blood
                                                                                                              vessels.
FDA   C54450   Patient Problem Codes FDA CDRH     C50798   Vaso-Vagal Response
FDA   C54450   Patient Problem Codes FDA CDRH     C3365    Venereal Disease                                   Any contagious disease acquired during            Disease (VD), venereal|VD|Venereal disease (VD)|VD, venereal disease
                                                                                                              sexual contact; e.g. syphilis, gonorrhea,
                                                                                                              chancroid.
FDA   C54450   Patient Problem   Codes FDA CDRH   C28221   Venipuncture
FDA   C54450   Patient Problem   Codes FDA CDRH   C50430   Ventilator Dependent                                                                                 Dependent, ventilator
FDA   C54450   Patient Problem   Codes FDA CDRH   C50448   Ventricle, Abnormality Of
FDA   C54450   Patient Problem   Codes FDA CDRH   C50799   Ventricular Fibrillation                           Arrhythmia characterized by fibrillary           Fibrillation, ventricular
                                                                                                              contractions of the ventricular muscle due to
                                                                                                              rapid repetitive excitation of myocardial fibers
                                                                                                              without coordinated contraction of the
                                                                                                              ventricle.
FDA   C54450   Patient Problem Codes FDA CDRH     C50800   Ventricular Flutter                                A ventricular tachyarrhythmia characterized Flutter, ventricular
                                                                                                              electrocardiographically by smooth
                                                                                                              undulating waves with QRS complexes
                                                                                                              merged with T waves, a rate of
                                                                                                              approximately 250 per minute.
FDA   C54450   Patient Problem Codes FDA CDRH     C50802   Ventricular Tachycardia                            An abnormally rapid ventricular rhythm with
                                                                                                              aberrant ventricular excitation, usually in
                                                                                                              excess of 150 beats per minute.

FDA   C54450   Patient Problem Codes FDA CDRH     C38057   Vertigo
FDA   C54450   Patient Problem Codes FDA CDRH     C50647   Vessel Or Plaque, Device Embedded In               Device and/or fragments of device are       Device embedded in vessel or plaque|Plaque or vessel, device embedded in
                                                                                                              embedded in patient's vessel and/or plaque.

FDA   C54450   Patient Problem Codes FDA CDRH     C50804   Vessels, Perforation Of                                                                              Perforation of vessel(s)
FDA   C54450   Patient Problem Codes FDA CDRH     C14283   Virus
FDA   C54450   Patient Problem Codes FDA CDRH     C50602   Vision, Impaired                                                                                     Impaired vision
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50638   Vision, Loss Of                                                                                     Loss of vision
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50805   Visual Disturbances                                                                                 Disturbances, visual
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50837   Vitrectomy
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50808   Vitreous floaters                                   Spots before the eyes; deposits in the       Floaters, Vitreous
                                                                                                                                                          vitreous of the eye, usually moving about
                                                                                                                                                          and probably representing fine aggregates of
                                                                                                                                                          vitreous protein occurring as a benign
                                                                                                                                                          degenerative change.
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50469   Vitreous Fluid, Blood In                                                                         Fluid, blood in vitreous|Blood in vitreous fluid
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50639   Vitreous Fluid, Loss Of                                                                          Fluid, loss of vitreous|Loss of vitreous fluid
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50807   Vitreous, Detachment Of                                                                          Detachment of vitreous
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50587   Vitritis                                            Inflammatory intraocular reaction with
                                                                                                                                                          clouding and cells in vitreous; often
                                                                                                                                                          accompanies inflammation of ciliary body,
                                                                                                                                                          iris, choroid, or retina.
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C3442    Vomiting
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50809   Weakness
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50810   Weight Fluctuations                                                                                Fluctuations of weight
FDA   C54450   Patient Problem   Codes FDA CDRH                                              C50811   Wheal(s)                                            A smooth, slightly elevated area on the body Welt(s)
                                                                                                                                                          surface, which is redder or paler than the
                                                                                                                                                          surrounding skin. It is the typical lesion of
                                                                                                                                                          urticaria, the dermal evidence of allergy, and
                                                                                                                                                          in sensitive persons may be provoked by
                                                                                                                                                          mechanical irritation of the skin.

FDA   C54450   Patient Problem Codes FDA CDRH                                                C50863   Wound Dehiscence                                                                                    Dehiscence wound
FDA   C54450   Patient Problem Codes FDA CDRH                                                C50704   Wound Infection, Post-Operative                                                                     Infection, post-operative wound|Post-operative wound infection
FDA   C54450   Patient Problem Codes FDA CDRH                                                C50705   Wound Infection, Post-Traumatic                                                                     Infection, post-traumatic wound|Post-traumatic wound infection
FDA   C54450   Patient Problem Codes FDA CDRH                                                C50435   Wrinkling
FDA   C54450   Patient Problem Codes FDA CDRH                                                C72898   Zonular Dehisence
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54356   Decrease Drug Level
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54614   Decreased Concomitant Drug AUC
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54615   Decreased Concomitant Drug Cmax
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54616   Decreased Concomitant Drug Half Life
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54358   Decreased Concomitant Drug Level
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54617   Decreased Concomitant Drug Tmax
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54609   Decreased Drug AUC
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54606   Decreased Drug Cmax
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54607   Decreased Drug Half Life
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54608   Decreased Drug Tmax
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54357   Increase Concomitant Drug Level
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54613   Increased Concomitant Drug AUC
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54610   Increased Concomitant Drug Cmax
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54611   Increased Concomitant Drug Half Life
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54612   Increased Concomitant Drug Tmax
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54605   Increased Drug AUC
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54602   Increased Drug Cmax
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54603   Increased Drug Half Life
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54355   Increased Drug Level
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54604   Increased Drug Tmax
FDA   C54600   Pharmacokinetic Effect Consequences Structured Product Labeling Terminology   C54354   Pharmacokinetic Effect Consequences
FDA   C54593   Reason For Non-Evaluation ICSR Terminology                                    C53601   Device Evaluation Anticipated But Not Yet Begun
FDA   C54593   Reason For Non-Evaluation ICSR Terminology                                    C53599   Device Not Made by Company
FDA   C54593   Reason For Non-Evaluation ICSR Terminology                                    C53600   Device Problem Already Known No Evaluation Necessary
FDA   C54593   Reason For Non-Evaluation ICSR Terminology                                    C53598   Device Received in Condition Which Made Analysis Impossible
FDA   C54593   Reason For Non-Evaluation ICSR Terminology                                    C17649   Other                                                                                               Other
FDA   C54593   Reason For Non-Evaluation ICSR Terminology                                    C53593   Reason for Non-Evaluation
FDA   C54587   Report Source ICSR Terminology                                                C15206   Clinical Study
FDA   C54587   Report Source ICSR Terminology                                                C51968   Company Representative
FDA   C54587   Report Source ICSR Terminology                                                C53568   Consumer
FDA   C54587   Report Source ICSR Terminology                                                C48289   Distributor
FDA   C54587   Report Source ICSR Terminology                                                C25512   Foreign
FDA   C54587   Report Source ICSR Terminology                                                C53287   Health Care Professional
FDA   C54587   Report Source ICSR Terminology                                                C50913   Invalid Data
FDA   C54587   Report Source ICSR Terminology                                                C48471   Literature
FDA   C54587   Report Source ICSR Terminology                                                C17649   Other                                                                                               Other
FDA   C54587   Report Source ICSR Terminology                                                C53566   Report Source
FDA   C54587   Report Source ICSR Terminology                                                C17998   Unknown                                                                                             Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known)
FDA   C54587   Report Source ICSR Terminology                                                C53567   User Facility                                     Device user facility means a hospital,
                                                                                                                                                        ambulatory surgical facility, nursing home,
                                                                                                                                                        outpatient diagnostic facility, or outpatient
                                                                                                                                                        treatment facility as defined in this section,
                                                                                                                                                        which is not a physician's office, as defined
                                                                                                                                                        in this section. School nurse offices and
                                                                                                                                                        employee health units are not device user
                                                                                                                                                        facilities.
FDA   C73600   Structured Product Labeling Business Operation Terminology                    C71586   EXPORT
FDA   C73600   Structured Product Labeling Business Operation Terminology                    C73599   IMPORT
FDA   C73600   Structured Product Labeling Business Operation Terminology                    C43360   MANUFACTURE
FDA   C73600   Structured Product Labeling Business Operation Terminology                    C73608   PRIVATE LABEL DISTRIBUTION
FDA   C73600   Structured Product Labeling Business Operation Terminology                    C73607   RELABEL
FDA   C73600   Structured Product Labeling Business Operation Terminology                    C73606   REPACK
FDA   C54453   Structured Product Labeling Color Terminology                                 C48323   BLACK                                             rgb(0, 0, 0)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48333   BLUE                                              rgb(0, 0, 255)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48332   BROWN                                             rgb(165, 42, 42)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48324   GRAY                                              rgb(128, 128, 128)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48329   GREEN                                             rgb(0, 128, 0)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48331   ORANGE                                            rgb(255, 165, 0)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48328   PINK                                              rgb(255, 192, 203)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48327   PURPLE                                            rgb(128, 0, 128)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48326   RED                                               rgb(255, 0, 0)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48556   SPL COLOR
FDA   C54453   Structured Product Labeling Color Terminology                                 C48334   TURQOUISE                                         rgb(64, 224, 208)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48325   WHITE                                             rgb(255, 255, 255)
FDA   C54453   Structured Product Labeling Color Terminology                                 C48330   YELLOW                                            rgb(255, 255, 0)
FDA   C54459   Structured Product Labeling DEA Schedule Terminology                          C48672   CI                                                Schedule I.
FDA   C54459   Structured Product Labeling DEA Schedule Terminology                          C48675   CII                                               Schedule II.
FDA   C54459   Structured Product Labeling DEA Schedule Terminology                          C48676   CIII                                              Schedule III.
FDA   C54459   Structured Product Labeling DEA Schedule Terminology                          C48677   CIV                                               Schedule IV.
FDA   C54459   Structured Product Labeling DEA Schedule Terminology                          C48679   CV                                                Schedule V.
FDA   C54459   Structured Product Labeling DEA Schedule Terminology                          C48670   SPL DEA Schedule                                  The abuse potential category to which an
                                                                                                                                                        active ingredient, or combination of active
                                                                                                                                                        ingredients, is assigned, as regulated by
                                                                                                                                                        both the United States Drug Enforcement
                                                                                                                                                        Administration (DEA) and the United States
                                                                                                                                                        Food and Drug Administration.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38192   AURICULAR (OTIC)                                  Administration to or by way of the ear.           OTIC
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38193   BUCCAL                                            Administration directed toward the cheek,
                                                                                                                                                        generally from within the mouth.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38194   CONJUNCTIVAL                                      Administration to the conjunctiva, the            CONJUNC
                                                                                                                                                        delicate membrane that lines the eyelids and
                                                                                                                                                        covers the exposed surface of the eyeball.

FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38675   CUTANEOUS                                           Administration to the skin.                     CUTAN
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38197   DENTAL                                              Administration to a tooth or teeth.             DENTAL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38633   ELECTRO-OSMOSIS                                     Administration of through the diffusion of      EL-OSMOS
                                                                                                                                                          substance through a membrane in an
                                                                                                                                                          electric field.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38205   ENDOCERVICAL                                        Administration within the canal of the cervix   E-CERVIC
                                                                                                                                                          uteri. Synonymous with the term
                                                                                                                                                          intracervical.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38206   ENDOSINUSIAL                                        Administration within the nasal sinuses of      E-SINUS
                                                                                                                                                          the head.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38208   ENDOTRACHEAL                                        Administration directly into the trachea.       E-TRACHE
                                                                                                                                                          Synonymous with the term intratracheal.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38209   ENTERAL                                             Administration directly into the intestines.    ENTER
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology          C38210   EPIDURAL                                            Administration upon or over the dura mater.     EPIDUR
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38211   EXTRA-AMNIOTIC                 Administration to the outside of the              X-AMNI
                                                                                                                              membrane enveloping the fetus.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38212   EXTRACORPOREAL                 Administration outside of the body.               X-CORPOR
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38200   HEMODIALYSIS                   Administration through hemodialysate fluid.       HEMO

FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38215   INFILTRATION                   Administration that results in substances         INFIL
                                                                                                                              passing into tissue spaces or into cells.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38219   INTERSTITIAL                   Administration to or in the interstices of a      INTERSTIT
                                                                                                                              tissue.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38220   INTRA-ABDOMINAL                Administration within the abdomen.                I-ABDOM
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38221   INTRA-AMNIOTIC                 Administration within the amnion.                 I-AMNI
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38222   INTRA-ARTERIAL                 Administration within an artery or arteries.      I-ARTER
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38223   INTRA-ARTICULAR                Administration within a joint.                    I-ARTIC
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38224   INTRABILIARY                   Administration within the bile, bile ducts or     I-BILI
                                                                                                                              gallbladder.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38225   INTRABRONCHIAL                 Administration within a bronchus.                 I-BRONCHI
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38226   INTRABURSAL                    Administration within a bursa.                    I-BURSAL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38227   INTRACARDIAC                   Administration within the heart.                  I-CARDI
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38228   INTRACARTILAGINOUS             Administration within a cartilage;                I-CARTIL
                                                                                                                              endochondral.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38229   INTRACAUDAL                    Administration within the cauda equina.           I-CAUDAL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38230   INTRACAVERNOUS                 Administration within a pathologic cavity,        I-CAVERN
                                                                                                                              such as occurs in the lung in tuberculosis.

FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38231   INTRACAVITARY                  Administration within a non-pathologic            I-CAVIT
                                                                                                                              cavity, such as that of the cervix, uterus, or
                                                                                                                              penis, or such as that is formed as the result
                                                                                                                              of a wound.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38232   INTRACEREBRAL                  Administration within the cerebrum.               I-CERE
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38233   INTRACISTERNAL                 Administration within the cisterna magna          I-CISTERN
                                                                                                                              cerebellomedularis.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38234   INTRACORNEAL                   Administration within the cornea (the             I-CORNE
                                                                                                                              transparent structure forming the anterior
                                                                                                                              part of the fibrous tunic of the eye).
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38217   INTRACORONAL, DENTAL           Administration of a drug within a portion of a    I-CORONAL
                                                                                                                              tooth which is covered by enamel and which
                                                                                                                              is separated from the roots by a slightly
                                                                                                                              constricted region known as the neck.

FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38218   INTRACORONARY                  Administration within the coronary arteries.      I-CORONARY

FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38235   INTRACORPORUS CAVERNOSUM       Administration within the dilatable spaces of     I-CORPOR
                                                                                                                              the corporus cavernosa of the penis.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38238   INTRADERMAL                    Administration within the dermis.               I-DERMAL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38239   INTRADISCAL                    Administration within a disc.                   I-DISCAL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38240   INTRADUCTAL                    Administration within the duct of a gland.      I-DUCTAL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38241   INTRADUODENAL                  Administration within the duodenum.             I-DUOD
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38242   INTRADURAL                     Administration within or beneath the dura.      I-DURAL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38243   INTRAEPIDERMAL                                                                 I-EPIDERM
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38245   INTRAESOPHAGEAL                Administration within the esophagus.            I-ESO
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38246   INTRAGASTRIC                   Administration within the stomach.              I-GASTRIC
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38247   INTRAGINGIVAL                  Administration within the gingivae.             I-GINGIV
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38249   INTRAILEAL                     Administration within the distal portion of the I-ILE
                                                                                                                              small intestine, from the jejunum to the
                                                                                                                              cecum.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38250   INTRALESIONAL                  Administration within or introduced directly    I-LESION
                                                                                                                              into a localized lesion.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38251   INTRALUMINAL                   Administration within the lumen of a tube.      I-LUMIN
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38252   INTRALYMPHATIC                 Administration within the lymph.                I-LYMPHAT
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38253   INTRAMEDULLARY                 Administration within the marrow cavity of a I-MEDUL
                                                                                                                              bone.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38254   INTRAMENINGEAL                 Administration within the meninges (the         I-MENIN
                                                                                                                              three membranes that envelope the brain
                                                                                                                              and spinal cord).
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C28161   INTRAMUSCULAR                  Administration within a muscle.                 IM
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38255   INTRAOCULAR                    Administration within the eye.                  I-OCUL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38256   INTRAOVARIAN                   Administration within the ovary.                I-OVAR
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38257   INTRAPERICARDIAL               Administration within the pericardium.          I-PERICARD
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38258   INTRAPERITONEAL                Administration within the peritoneal cavity.    I-PERITON

FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38259   INTRAPLEURAL                   Administration within the pleura.                 I-PLEURAL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38260   INTRAPROSTATIC                 Administration within the prostate gland.         I-PROSTAT
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38261   INTRAPULMONARY                 Administration within the lungs or its            I-PULMON
                                                                                                                              bronchi.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38262   INTRASINAL                     Administration within the nasal or periorbital    I-SINAL
                                                                                                                              sinuses.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38263   INTRASPINAL                    Administration within the vertebral column.       I-SPINAL

FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38264   INTRASYNOVIAL                  Administration within the synovial cavity of a    I-SYNOV
                                                                                                                              joint.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38265   INTRATENDINOUS                 Administration within a tendon.                   I-TENDIN
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38266   INTRATESTICULAR                Administration within the testicle.               I-TESTIC
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38267   INTRATHECAL                    Administration within the cerebrospinal fluid     IT
                                                                                                                              at any level of the cerebrospinal axis,
                                                                                                                              including injection into the cerebral
                                                                                                                              ventricles.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38207   INTRATHORACIC                  Administration within the thorax (internal to     I-THORAC
                                                                                                                              the ribs); synonymous with the term
                                                                                                                              endothoracic.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38268   INTRATUBULAR                   Administration within the tubules of an           I-TUBUL
                                                                                                                              organ.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38269   INTRATUMOR                     Administration within a tumor.                    I-TUMOR
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38270   INTRATYMPANIC                  Administration within the auris media.            I-TYMPAN
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38272   INTRAUTERINE                   Administration within the uterus.                 I-UTER
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38273   INTRAVASCULAR                  Administration within a vessel or vessels.        I-VASC
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38276   INTRAVENOUS                    Administration within or into a vein or veins.    IV

FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38274   INTRAVENOUS BOLUS              Administration within or into a vein or veins     IV BOLUS
                                                                                                                              all at once.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38279   INTRAVENOUS DRIP               Administration within or into a vein or veins     IV DRIP
                                                                                                                              over a sustained period of time.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38277   INTRAVENTRICULAR               Administration within a ventricle.                I-VENTRIC
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38278   INTRAVESICAL                   Administration within the bladder.                I-VESIC
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38280   INTRAVITREAL                   Administration within the vitreous body of the    I-VITRE
                                                                                                                              eye.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38203   IONTOPHORESIS                  Administration by means of an electric            ION
                                                                                                                              current where ions of soluble salts migrate
                                                                                                                              into the tissues of the body.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38281   IRRIGATION                     Administration to bathe or flush open             IRRIG
                                                                                                                              wounds or body cavities.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38282   LARYNGEAL                      Administration directly upon the larynx.          LARYN
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38284   NASAL                          Administration to the nose; administered by       NASAL
                                                                                                                              way of the nose.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38285   NASOGASTRIC                    Administration through the nose and into the      NG
                                                                                                                              stomach, usually by means of a tube.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C48623   NOT APPLICABLE                 Routes of administration are not applicable.      NA

FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38286   OCCLUSIVE DRESSING TECHNIQUE   Administration by the topical route which is      OCCLUS
                                                                                                                              then covered by a dressing which occludes
                                                                                                                              the area.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38287   OPHTHALMIC                     Administration to the external eye.               OPHTHALM
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38288   ORAL                           Administration to or by way of the mouth.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38289   OROPHARYNGEAL                  Administration directly to the mouth and          ORO
                                                                                                                              pharynx.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38290   OTHER                          Administration is different from others on this
                                                                                                                              list.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38291   PARENTERAL                     Administration by injection, infusion, or         PAREN
                                                                                                                              implantation.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38676   PERCUTANEOUS               Administration through the skin.                   PERCUT
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38292   PERIARTICULAR              Administration around a joint.                     P-ARTIC
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38677   PERIDURAL                  Administration to the outside of the dura          P-DURAL
                                                                                                                          mater of the spinal cord.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38293   PERINEURAL                 Administration surrounding a nerve or              P-NEURAL
                                                                                                                          nerves.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38294   PERIODONTAL                Administration around a tooth.                     P-ODONT
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38295   RECTAL                     Administration to the rectum.                      RECTAL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38216   RESPIRATORY (INHALATION)   Administration within the respiratory tract by     RESPIR
                                                                                                                          inhaling orally or nasally for local or systemic
                                                                                                                          effect.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38296   RETROBULBAR                Administration behind the pons or behind           RETRO
                                                                                                                          the eyeball.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38114   ROUTE OF ADMINISTRATION
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38198   SOFT TISSUE                Administration into any soft tissue.               SOFT TIS
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38297   SUBARACHNOID               Administration beneath the arachnoid.              S-ARACH
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38298   SUBCONJUNCTIVAL            Administration beneath the conjunctiva.            S-CONJUNC
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38299   SUBCUTANEOUS               Administration beneath the skin;                   SC
                                                                                                                          hypodermic. Synonymous with the term
                                                                                                                          SUBDERMAL.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38300   SUBLINGUAL                 Administration beneath the tongue.                 SL
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38301   SUBMUCOSAL                 Administration beneath the mucous                  S-MUCOS
                                                                                                                          membrane.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38304   TOPICAL                    Administration to a particular spot on the         TOPIC
                                                                                                                          outer surface of the body. The E2B term
                                                                                                                          TRANSMAMMARY is a subset of the term
                                                                                                                          TOPICAL.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38305   TRANSDERMAL                Administration through the dermal layer of         T-DERMAL
                                                                                                                          the skin to the systemic circulation by
                                                                                                                          diffusion.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38283   TRANSMUCOSAL               Administration across the mucosa.                  T-MUCOS
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38307   TRANSPLACENTAL             Administration through or across the               T-PLACENT
                                                                                                                          placenta.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38308   TRANSTRACHEAL              Administration through the wall of the             T-TRACHE
                                                                                                                          trachea.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38309   TRANSTYMPANIC              Administration across or through the               T-TYMPAN
                                                                                                                          tympanic cavity.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38310   UNASSIGNED                 Route of administration has not yet been           UNAS
                                                                                                                          assigned.
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38311   UNKNOWN                    Route of administration is unknown.                UNKNOWN
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38312   URETERAL                   Administration into the ureter.                    URETER
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38271   URETHRAL                   Administration into the urethra.                   URETH
FDA   C54455   Structured Product Labeling Drug Route of Administration Terminology   C38313   VAGINAL                    Administration into the vagina.                    VAGIN
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73360   ALMOND                     LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73361   ANISE                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73362   APPLE                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73363   APRICOT                    LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73364   BANANA                     LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73365   BERRY                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73366   BLACKBERRY                 LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73367   BLUEBERRY                  LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73368   BUBBLE GUM                 LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73369   BURGUNDY                   LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73370   BUTTER PECAN               LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73371   BUTTERMINT                 LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73372   BUTTERSCOTCH               LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73373   CARAMEL                    LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73374   CHEESE                     LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73375   CHERRY                     LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73376   CHOCOLATE                  LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73377   CINNAMON                   LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73378   CITRUS                     LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73379   COCONUT                    LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73380   COFFEE                     LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73381   COLA                       LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73382   COTTON CANDY               LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73383   CRANBERRY                  LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73384   CREME DE MENTHE            LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73385   CURACAO                    LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73386   CUSTARD                    LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73387   EGG NOG                    LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73388   FIG                        LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73389   FRUIT                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73390   FRUIT PUNCH                LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73391   GRAPE                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73392   GRAPEFRUIT                 LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73393   GUARANA                    LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73394   HONEY                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73395   KIWI                       LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73396   LEMON                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73397   LICORICE                   LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73398   LIME                       LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73399   LIVER                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73400   MANGO                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73433   MAQUE TREE                 LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73402   MEAT                       LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73403   MENTHOL                    LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73404   MINT                       LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73405   ORANGE                     LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73406   ORANGE BANANA              LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73407   PEACH                      LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73408   PEPPERMINT                 LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73409   PINEAPPLE                  LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73410   PLUM                       LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73411   POMEGRANATE                LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73412   RAISIN                     LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73413   RASPBERRY                  LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73414   ROOT BEER                  LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73415   RUM                        LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73416   SPEARMINT                  LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73338   SPLFLAVOR                  A characteristic of a dosage form of a
                                                                                                                          medicinal product, specifying the most
                                                                                                                          predominant flavor. SPLFLAVOR is not an
                                                                                                                          FDA specification for the names of specific
                                                                                                                          flavors that may appear as inactive
                                                                                                                          ingredients in labeling
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73417   STRAWBERRY                 LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73418   TANGERINE                  LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73419   TROPICAL FRUIT PUNCH       LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73420   TUTTI FRUTTI               LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73421   VANILLA                    LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73422   WALNUT                     LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73423   WATERMELON                 LITERAL
FDA   C73339   Structured Product Labeling Flavor Terminology                         C73424   WINTERGREEN                LITERAL
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73583   ANADA
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73584   ANDA
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73585   BLA
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73586   BULK ACTIVE INGREDIENT
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73587   BULK INACTIVE INGREDIENT
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73626   BULK INGREDIENT
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73588   CONDITIONAL NADA
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73590   EXPORT ONLY
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73593   NADA
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73594   NDA
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73605   NDA AUTHORIZED GENERIC
FDA   C73582   Structured Product Labeling Marketing Category Terminology             C73603   OTC MONOGRAPH FINAL        Product marketed under a finalized OTC
                                                                                                                          Monograph.
FDA   C73582   Structured Product Labeling Marketing Category Terminology              C73604   OTC MONOGRAPH NOT FINAL         Product marketed under an OTC
                                                                                                                                monograph not yet finalized.
FDA   C73582   Structured Product Labeling Marketing Category Terminology              C73581   SPL MARKETING CATEGORY
FDA   C73582   Structured Product Labeling Marketing Category Terminology              C73614   UNAPPROVED HOMEOPATHIC
FDA   C73582   Structured Product Labeling Marketing Category Terminology              C73613   UNAPPROVED MEDICAL GAS
FDA   C73582   Structured Product Labeling Marketing Category Terminology              C73627   UNAPPROVED OTHER
FDA   C73582   Structured Product Labeling Marketing Category Terminology              C73615   UNAPPROVED VITAMIN DRUG
FDA   C54619   Structured Product Labeling Medical Product Intent Of Use Terminology   C54415   Diagnostic For
FDA   C54619   Structured Product Labeling Medical Product Intent Of Use Terminology   C54390   Medical Product Intent Of Use
FDA   C54619   Structured Product Labeling Medical Product Intent Of Use Terminology   C54416   Mitigation
FDA   C54619   Structured Product Labeling Medical Product Intent Of Use Terminology   C54404   Prophylaxis For
FDA   C54619   Structured Product Labeling Medical Product Intent Of Use Terminology   C54398   Treat
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43165   AMPULE                          A container capable of being hermetically          AMP
                                                                                                                                sealed, intended to hold sterile materials.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43166   APPLICATOR                      A pre-filled non-injectable pipette, syringe or    AP
                                                                                                                                tube.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43167   BAG                             A sac or pouch.                                    BAG
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43168   BLISTER PACK                    A package that consists of molded plastic or       BLPK
                                                                                                                                laminate that has indentations (viewed as
                                                                                                                                'blisters' when flipped) into which a dosage
                                                                                                                                form, is placed. A covering, usually of
                                                                                                                                laminated material, is then sealed to the
                                                                                                                                molded part. A strip pack is a specialized
                                                                                                                                type of blister pack where there are no pre-
                                                                                                                                formed or molded parts; in this case there
                                                                                                                                are two flexible layers that are sealed with
                                                                                                                                the dosage form in between. Suppositories
                                                                                                                                that are strip packed between two layers of
                                                                                                                                foil are also considered a blister pack.

FDA   C54457   Structured Product Labeling Package Type Terminology                    C43169   BOTTLE                          A vessel with a narrow neck designed to            BOT
                                                                                                                                accept a specific closure.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43170   BOTTLE, DISPENSING              A bottle that is used by the pharmacist to         BOTDIS
                                                                                                                                dispense the prescribed medication. It
                                                                                                                                includes preparations for which a dropper
                                                                                                                                accompanies the bottle.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43171   BOTTLE, DROPPER                 A bottle that has a device specifically            BOTDR
                                                                                                                                intended for the application of a liquid in a
                                                                                                                                drop by drop manner, or a device intended
                                                                                                                                for the delivery of an exact dose (e.g.,
                                                                                                                                calibrated dropper for oral medications).

FDA   C54457   Structured Product Labeling Package Type Terminology                    C43172   BOTTLE, GLASS                   A glass vessel with a narrow neck designed         BOTGL
                                                                                                                                to accept a specific closure.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43173   BOTTLE, PLASTIC                 A plastic vessel with a narrow neck designed       BOTPL
                                                                                                                                to accept a specific closure.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43174   BOTTLE, PUMP                    A bottle that is fitted with a pumping             BOTPU
                                                                                                                                mechanism for the administration of drug
                                                                                                                                product.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43175   BOTTLE, SPRAY                   A bottle that is fitted with an atomizer or a      BOTSPR
                                                                                                                                device which produces finely divided liquid
                                                                                                                                carried by air.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43176   BOTTLE, UNIT-DOSE               A bottle that contains a single whole dose of      BOTUD
                                                                                                                                a non-parenteral drug product.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43177   BOTTLE, WITH APPLICATOR         A bottle which includes a device for applying      BOTAP
                                                                                                                                its contents.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43178   BOX                             A square or rectangular vessel, usually
                                                                                                                                made of cardboard or plastic.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43179   BOX, UNIT-DOSE                  A box that contains a single dose of a non-        BOXUD
                                                                                                                                parenteral drug product. [Note: Boxes that
                                                                                                                                contain 100 unit dose blister packs should
                                                                                                                                be classified under blister pack, since this is
                                                                                                                                the immediate container into which the
                                                                                                                                dosage form is placed.]

FDA   C54457   Structured Product Labeling Package Type Terminology                    C43180   CAN                             A cylindrical vessel, usually made of metal.

FDA   C54457   Structured Product Labeling Package Type Terminology                    C43181   CANISTER                        A type of can for holding a drug product.          CSTR
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43182   CARTON                          A cardboard box or container which is              CRTN
                                                                                                                                usually considered a secondary packaging
                                                                                                                                component.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43183   CARTRIDGE                       A container consisting of a cylinder with a        CTG
                                                                                                                                septum at one end, and a seal at the other
                                                                                                                                end, which is inserted into a device to form a
                                                                                                                                syringe which contains a single dose of a
                                                                                                                                parenteral drug product.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43184   CASE                            A receptacle for holding something (e.g.,          CASE
                                                                                                                                that into which some oral contraceptive
                                                                                                                                blister packs are placed).
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43185   CELLO PACK                      A plastic 'clamshell' [thin plastic pre-formed     CELLO
                                                                                                                                structure for a device].
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43186   CONTAINER                       A receptacle designed to hold a specific           CTR
                                                                                                                                dosage form.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43187   CUP                             A bowl-shaped container.                           CUP
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43188   CUP, UNIT-DOSE                  A cup intended to hold a single dose of a          CUPUD
                                                                                                                                non-parenteral drug product.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43189   CYLINDER                        A container designed specifically to hold          CYL
                                                                                                                                gases.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43190   DEWAR                           A container, usually made of glass or metal,       DEW
                                                                                                                                that has at least two walls with the space
                                                                                                                                between each wall evacuated so as to
                                                                                                                                prevent the transfer of heat. The inside of the
                                                                                                                                container often has a coating (as silvering)
                                                                                                                                on the inside to reduce heat transfer, and is
                                                                                                                                used especially for storing liquified gases or
                                                                                                                                for experiments at low temperatures. The
                                                                                                                                size can vary from that of a small thermos
                                                                                                                                bottle up to that which may be mounted
                                                                                                                                upon a large truck (also known as a
                                                                                                                                'cryogenic truck').
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43191   DIALPACK                        A dose pack container designed to assist           DLPK
                                                                                                                                with patient compliance. The patient turns a
                                                                                                                                dial to the correct day and the correct dose
                                                                                                                                is made available and the container
                                                                                                                                indicates that the dose has been removed.

FDA   C54457   Structured Product Labeling Package Type Terminology                    C43192   DOSE PACK                       A container in which a preselected dose or         DSPK
                                                                                                                                dose regimen of the medication is placed.

FDA   C54457   Structured Product Labeling Package Type Terminology                    C43193   DRUM                            A straight-sided cylindrical shipping              DRUM
                                                                                                                                container with flat ends; one of which can be
                                                                                                                                opened/closed.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C16738   INHALER                         A device by means of which a medicinal             INHL
                                                                                                                                product can be administered by inspiration
                                                                                                                                through the nose or the mouth.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43194   INHALER, REFILL                 A container of medication intended to refill       INHLRE
                                                                                                                                an inhaler.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43195   JAR                             A rigid container having a wide mouth and          JAR
                                                                                                                                often no neck which typically holds solid or
                                                                                                                                semisolid drug products.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43196   JUG                             A large, deep container that has a narrow          JUG
                                                                                                                                mouth, is typically fitted with a handle, and is
                                                                                                                                used to hold liquids.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C43197   KIT                             A package which includes a container of
                                                                                                                                drug product(s) and the equipment and
                                                                                                                                supplies used with it.
FDA   C54457   Structured Product Labeling Package Type Terminology                    C48626   NOT STATED                      The package type is not stated or is               NS
                                                                                                                                unavailable.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43233   PACKAGE                        The drug product container with any                PKG
                                                                                                                            accompanying materials or components.
                                                                                                                            This may include the protective packaging,
                                                                                                                            labeling, administration devices, etc.

FDA   C54457   Structured Product Labeling Package Type Terminology                 C43164   PACKAGE TYPE
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43198   PACKAGE, COMBINATION           A package in which two or more drug           PKGCOM
                                                                                                                            products that are normally available
                                                                                                                            separately are now available together.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43199   PACKET                         An envelope into which only one dose of a     PKT
                                                                                                                            drug product, usually in the form of granules
                                                                                                                            or powder, has been directly placed. An
                                                                                                                            example includes glassine powder paper
                                                                                                                            containing aspirin. Other examples include
                                                                                                                            aluminum foil packets into which alcohol
                                                                                                                            swabs and pledgets are placed.

FDA   C54457   Structured Product Labeling Package Type Terminology                 C43200   POUCH                          A flexible container used to protect or hold       POU
                                                                                                                            one or more doses of a drug product (e.g. a
                                                                                                                            pouch into which oral contraceptive blister
                                                                                                                            packs are inserted, and an overwrap pouch
                                                                                                                            for large volume parenterals).

FDA   C54457   Structured Product Labeling Package Type Terminology                 C43201   SUPERSACK                      A multilayer paper bag for shipping some           SUPSACK
                                                                                                                            solid bulk excipients, usually in the form of
                                                                                                                            powder or granules.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43202   SYRINGE                        A device for the administration of parenteral      SYR
                                                                                                                            drug products that consists of a rigid barrel
                                                                                                                            fitted with septum with a plunger at one end
                                                                                                                            and a seal or needle at the other end. The
                                                                                                                            needle assembly may be part of the device
                                                                                                                            or separate.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43203   SYRINGE, GLASS                 A device for the administration of parenteral      SYRGL
                                                                                                                            drug products that consists of a rigid glass
                                                                                                                            barrel fitted with septum with a plunger at
                                                                                                                            one end and a seal or needle at the other
                                                                                                                            end. The needle assembly may be part of
                                                                                                                            the device or separate.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43204   SYRINGE, PLASTIC               A device for the administration of parenteral      SYRPL
                                                                                                                            drug products that consists of a rigid plastic
                                                                                                                            barrel fitted with septum with a plunger at
                                                                                                                            one end and a seal or needle at the other
                                                                                                                            end. The needle assembly may be part of
                                                                                                                            the device or separate.

FDA   C54457   Structured Product Labeling Package Type Terminology                 C43205   TABMINDER                      A specialized package; it registers each time      TABMIND
                                                                                                                            it is opened and is used for checking patient
                                                                                                                            compliance to prescribed medication
                                                                                                                            regimens.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43206   TANK                           A large receptacle used for holding,
                                                                                                                            transporting, or storing liquids or gases, and
                                                                                                                            often referred to as a reservoir.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C53438   TRAY                           A shallow flat receptacle, with a raised edge      TRAY
                                                                                                                            or rim,used for carrying, holding, or
                                                                                                                            displaying finished drug product in its
                                                                                                                            primary or market package. A tray and its
                                                                                                                            contents may be encased in shrink-wrapped
                                                                                                                            plastic for shipping, or with a cover or an
                                                                                                                            overwrap as part of a unit of use package or
                                                                                                                            kit.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C42794   TUBE                           A flexible container for semisolid drug
                                                                                                                            products which is flattened and crimped or
                                                                                                                            sealed at one end and has a reclosable
                                                                                                                            opening at the other.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43207   TUBE, WITH APPLICATOR          A tube which is provided with a device (the        TUBEAP
                                                                                                                            applicator) for administering the dosage
                                                                                                                            form. The applicator may be part of the tube
                                                                                                                            closure or be separate.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43226   VIAL                           A container designed for use with parenteral       VIAL
                                                                                                                            drug products.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43208   VIAL, DISPENSING               A vial that is used by the pharmacist to           VIALDIS
                                                                                                                            dispense the prescribed medication.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43209   VIAL, GLASS                    A glass container designed for use with            VIALGL
                                                                                                                            parenteral drug products.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43210   VIAL, MULTI-DOSE               A vial intended to contain more than one           VIALMD
                                                                                                                            dose of the drug product.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43211   VIAL, PATENT DELIVERY SYSTEM   A vial that has a patented delivery system.        VIALPAT

FDA   C54457   Structured Product Labeling Package Type Terminology                 C43212   VIAL, PHARMACY BULK PACKAGE    A container of a sterile preparation whose         VIALPHR
                                                                                                                            contents are intended for use in a pharmacy
                                                                                                                            admixture program and are restricted to the
                                                                                                                            preparation of admixtures for infusion or,
                                                                                                                            through a sterile transfer device, for the filling
                                                                                                                            of empty sterile syringes.

FDA   C54457   Structured Product Labeling Package Type Terminology                 C43213   VIAL, PIGGYBACK                A vial that contains a parenteral preparation VIALPIG
                                                                                                                            that can be attached directly to the tubing of
                                                                                                                            a parenterally administered fluid.

FDA   C54457   Structured Product Labeling Package Type Terminology                 C43214   VIAL, PLASTIC                  A plastic container designed for use with          VIALPL
                                                                                                                            parenteral drug products.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43215   VIAL, SINGLE-DOSE              A vial containing a single unit of a parenteral    VIALSD
                                                                                                                            drug product.
FDA   C54457   Structured Product Labeling Package Type Terminology                 C43216   VIAL, SINGLE-USE               A vial where a single dose of a parenteral         VIALSU
                                                                                                                            drug product can be removed, and then the
                                                                                                                            vial and its remaining contents can be
                                                                                                                            disposed.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42887   AEROSOL                        A product that is packaged under pressure          AER
                                                                                                                            and contains therapeutically active
                                                                                                                            ingredients that are released upon activation
                                                                                                                            of an appropriate valve system; it is intended
                                                                                                                            for topical application to the skin as well as
                                                                                                                            local application into the nose (nasal
                                                                                                                            aerosols), mouth (lingual aerosols), or lungs
                                                                                                                            (inhalation aerosols).
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42888   AEROSOL, FOAM                  A dosage form containing one or more active        AER FOAM
                                                                                                                            ingredients, surfactants, aqueous or non-
                                                                                                                            aqueous liquids, and the propellants; if the
                                                                                                                            propellant is in the internal (discontinuous)
                                                                                                                            phase (i.e., of the oil-in-water type), a stable
                                                                                                                            foam is discharged, and if the propellant is in
                                                                                                                            the external (continuous) phase (i.e., of the
                                                                                                                            water-in-oil type), a spray or a quick-breaking
                                                                                                                            foam is discharged.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42960   AEROSOL, METERED               A pressurized dosage form consisting of        AER MET
                                                                                                                            metered dose valves which allow for the
                                                                                                                            delivery of a uniform quantity of spray upon
                                                                                                                            each activation.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42971   AEROSOL, POWDER                A product that is packaged under pressure AER PWD
                                                                                                                            and contains therapeutically active
                                                                                                                            ingredients, in the form of a powder, that are
                                                                                                                            released upon activation of an appropriate
                                                                                                                            valve system.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42889   AEROSOL, SPRAY                              An aerosol product which utilizes a           AER SPRAY
                                                                                                                                         compressed gas as the propellant to provide
                                                                                                                                         the force necessary to expel the product as a
                                                                                                                                         wet spray; it is applicable to solutions of
                                                                                                                                         medicinal agents in aqueous solvents.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42892   BAR, CHEWABLE                               A solid dosage form usually in the form of a       BAR CHEW
                                                                                                                                         rectangle that is meant to be chewed.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42890   BEAD                                        A solid dosage form in the shape of a small        BEAD
                                                                                                                                         ball.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C43451   BEAD, IMPLANT, EXTENDED RELEASE             A small sterile solid mass consisting of a         BEAD IMP ER
                                                                                                                                         highly purified drug intended for implantation
                                                                                                                                         in the body which would allow at least a
                                                                                                                                         reduction in dosing frequency as compared
                                                                                                                                         to that drug presented as a conventional
                                                                                                                                         dosage form.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42891   BLOCK                                       Solid dosage form, usually in the shape of a       BLOCK
                                                                                                                                         square or rectangle.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C25158   CAPSULE                                     A solid oral dosage form consisting of a shell     CAP
                                                                                                                                         and a filling. The shell is composed of a
                                                                                                                                         single sealed enclosure, or two halves that fit
                                                                                                                                         together and which are sometimes sealed
                                                                                                                                         with a band. Capsule shells may be made
                                                                                                                                         from gelatin, starch, or cellulose, or other
                                                                                                                                         suitable materials, may be soft or hard, and
                                                                                                                                         are filled with solid or liquid ingredients that
                                                                                                                                         can be poured or squeezed.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42895   CAPSULE, COATED                             A solid dosage form in which the drug is           CAP COATED
                                                                                                                                         enclosed within either a hard or soft soluble
                                                                                                                                         container or "shell" made from a suitable
                                                                                                                                         form of gelatin; additionally, the capsule is
                                                                                                                                         covered in a designated coating.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42896   CAPSULE, COATED PELLETS                     A solid dosage form in which the drug is        CAP COATED PELLETS
                                                                                                                                         enclosed within either a hard or soft soluble
                                                                                                                                         container or "shell" made from a suitable
                                                                                                                                         form of gelatin; the drug itself is in the form
                                                                                                                                         of granules to which varying amounts of
                                                                                                                                         coating have been applied.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42917   CAPSULE, COATED, EXTENDED RELEASE           A solid dosage form in which the drug is        CAP COATED ER
                                                                                                                                         enclosed within either a hard or soft soluble
                                                                                                                                         container or "shell" made from a suitable
                                                                                                                                         form of gelatin; additionally, the capsule is
                                                                                                                                         covered in a designated coating, and which
                                                                                                                                         releases a drug (or drugs) in such a manner
                                                                                                                                         to allow at least a reduction in dosing
                                                                                                                                         frequency as compared to that drug (or
                                                                                                                                         drugs) presented as a conventional dosage
                                                                                                                                         form.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42902   CAPSULE, DELAYED RELEASE                    A solid dosage form in which the drug is        CAP DR
                                                                                                                                         enclosed within either a hard or soft soluble
                                                                                                                                         container made from a suitable form of
                                                                                                                                         gelatin, and which releases a drug (or drugs)
                                                                                                                                         at a time other than promptly after
                                                                                                                                         administration. Enteric-coated articles are
                                                                                                                                         delayed release dosage forms.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42904   CAPSULE, DELAYED RELEASE PELLETS            A solid dosage form in which the drug is           CAP DR PELLETS
                                                                                                                                         enclosed within either a hard or soft soluble
                                                                                                                                         container or "shell" made from a suitable
                                                                                                                                         form of gelatin; the drug itself is in the form
                                                                                                                                         of granules to which enteric coating has
                                                                                                                                         been applied, thus delaying release of the
                                                                                                                                         drug until its passage into the intestines.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42916   CAPSULE, EXTENDED RELEASE              A solid dosage form in which the drug is      CAP ER
                                                                                                                                    enclosed within either a hard or soft soluble
                                                                                                                                    container made from a suitable form of
                                                                                                                                    gelatin, and which releases a drug (or drugs)
                                                                                                                                    in such a manner to allow a reduction in
                                                                                                                                    dosing frequency as compared to that drug
                                                                                                                                    (or drugs) presented as a conventional
                                                                                                                                    dosage form.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42928   CAPSULE, FILM COATED, EXTENDED RELEASE A solid dosage form in which the drug is      CAP FILM COATED ER
                                                                                                                                    enclosed within either a hard or soft soluble
                                                                                                                                    container or "shell" made from a suitable
                                                                                                                                    form of gelatin; additionally, the capsule is
                                                                                                                                    covered in a designated film coating, and
                                                                                                                                    which releases a drug (or drugs) in such a
                                                                                                                                    manner to allow at least a reduction in
                                                                                                                                    dosing frequency as compared to that drug
                                                                                                                                    (or drugs) presented as a conventional
                                                                                                                                    dosage form.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42936   CAPSULE, GELATIN COATED                A solid dosage form in which the drug is      CAP GELATIN COATED
                                                                                                                                    enclosed within either a hard or soft soluble
                                                                                                                                    container made from a suitable form of
                                                                                                                                    gelatin; through a banding process, the
                                                                                                                                    capsule is coated with additional layers of
                                                                                                                                    gelatin so as to form a complete seal.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42954   CAPSULE, LIQUID FILLED                      A solid dosage form in which the drug is       CAP LIQ FILLED
                                                                                                                                         enclosed within a soluble, gelatin shell which
                                                                                                                                         is plasticized by the addition of a polyol,
                                                                                                                                         such as sorbitol or glycerin, and is therefore
                                                                                                                                         of a somewhat thicker consistency than that
                                                                                                                                         of a hard shell capsule; typically, the active
                                                                                                                                         ingredients are dissolved or suspended in a
                                                                                                                                         liquid vehicle.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C45414   CEMENT                                      A substance that serves to produce solid           CEMENT
                                                                                                                                         union between two surfaces.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42678   CIGARETTE                                   A narrow tube filled with material that is         CIGARETTE
                                                                                                                                         capable to burn with release of
                                                                                                                                         therapeutically-active substance(s) during
                                                                                                                                         the process of smoking. Cigarette is a very
                                                                                                                                         efficient drug-delivery inhaler system for fast-
                                                                                                                                         acting substances.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60884   CLOTH                                       A large piece of relatively flat, absorbent        CLOTH
                                                                                                                                         material that contains a drug. It is typically
                                                                                                                                         used for applying medication or for
                                                                                                                                         cleansing.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60891   CONCENTRATE                                 A liquid preparation of increased strength         CONC
                                                                                                                                         and reduced volume which is usually diluted
                                                                                                                                         prior to administration.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42900   CONE                                        A solid dosage form bounded by a circular          CONE
                                                                                                                                         base and the surface formed by line
                                                                                                                                         segments joining every point of the
                                                                                                                                         boundary of the base to a common vertex. A
                                                                                                                                         cone (usually containing antibiotics) is
                                                                                                                                         normally placed below the gingiva after a
                                                                                                                                         dental extraction.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42919   CORE, EXTENDED RELEASE                      An ocular system placed in the eye from            CORE ER
                                                                                                                                         which the drug diffuses through a
                                                                                                                                         membrane at a constant rate over a
                                                                                                                                         specified period.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C28944   CREAM                              An emulsion, semisolid (1) dosage form,
                                                                                                                                usually containing > 20% water and volatiles
                                                                                                                                (2) and/or < 50% hydrocarbons, waxes, or
                                                                                                                                polyols as the vehicle. This dosage form is
                                                                                                                                generally for external application to the skin
                                                                                                                                or mucous membranes. Note 1: A semisolid
                                                                                                                                is not pourable; it does not flow or conform
                                                                                                                                to its container at room temperature. It does
                                                                                                                                not flow at low shear stress and generally
                                                                                                                                exhibits plastic flow behavior. Note 2:
                                                                                                                                Percent water and volatiles are measured by
                                                                                                                                a loss on drying test in which the sample is
                                                                                                                                heated at 105 degrees C until constant
                                                                                                                                weight is achieved.


FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60897   CREAM, AUGMENTED                   A cream dosage form that enhances drug              CREAM AUG
                                                                                                                                delivery. Augmentation does not refer to the
                                                                                                                                strength of the drug in the dosage form.
                                                                                                                                NOTE: CDER has decided to refrain from
                                                                                                                                expanding the use of this dosage form due
                                                                                                                                to difficulties in setting specific criteria that
                                                                                                                                must be met to be considered augmented.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42901   CRYSTAL                            A naturally produced angular solid of definite      CRYSTAL
                                                                                                                                form in which the ultimate units from which it
                                                                                                                                is built up are systematically arranged; they
                                                                                                                                are usually evenly spaced on a regular
                                                                                                                                space lattice.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47890   DIAPHRAGM                          A device usually dome-shaped, worn during           DIAPHRAM
                                                                                                                                copulation over the cervical mouth for
                                                                                                                                prevention of conception or infection.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C43525   DISC                               A circular plate-like organ or structure.           DISC
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42679   DOUCHE                             A liquid preparation, intended for the              DOUCHE
                                                                                                                                irrigative cleansing of the vagina, that is
                                                                                                                                prepared from powders, liquid solutions, or
                                                                                                                                liquid concentrates and contains one or
                                                                                                                                more chemical substances dissolved in a
                                                                                                                                suitable solvent or mutually miscible
                                                                                                                                solvents.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42763   DRESSING                           The application of various materials for            DRESSING
                                                                                                                                protecting a wound.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C17423   DRUG DELIVERY SYSTEM               Modern technology, distributed with or as a         DDS
                                                                                                                                part of a drug product that allows for the
                                                                                                                                uniform release or targeting of drugs to the
                                                                                                                                body.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42912   ELIXIR                             A clear, pleasantly flavored, sweetened             ELIXIR
                                                                                                                                hydroalcoholic liquid containing dissolved
                                                                                                                                medicinal agents; it is intended for oral use.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42913   EMULSION                           A dosage form consisting of a two-phase       EMULSION
                                                                                                                                system comprised of at least two immiscible
                                                                                                                                liquids (1), one of which is dispersed as
                                                                                                                                droplets (internal or dispersed phase) within
                                                                                                                                the other liquid (external or continuous
                                                                                                                                phase), generally stabilized with one or more
                                                                                                                                emulsifying agents. Note 1: A liquid is
                                                                                                                                pourable; it flows and conforms to its
                                                                                                                                container at room temperature. It displays
                                                                                                                                Newtonian or pseudoplastic flow behavior.
                                                                                                                                Note 2: Emulsion is used as a dosage form
                                                                                                                                term unless a more specific term is
                                                                                                                                applicable, e.g. cream, lotion, ointment.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42915   ENEMA                              A rectal preparation for therapeutic,
                                                                                                                                diagnostic, or nutritive purposes.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42929   EXTRACT                            A concentrated preparation of vegetable or      EXTRACT
                                                                                                                                animal drugs obtained by removal of the
                                                                                                                                active constituents of the respective drugs
                                                                                                                                with a suitable menstrua, evaporation of all
                                                                                                                                or nearly all of the solvent, and adjustment of
                                                                                                                                the residual masses or powders to the
                                                                                                                                prescribed standards.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60926   FIBER, EXTENDED RELEASE            A slender and elongated solid thread-like    FIBER ER
                                                                                                                                substance that delivers drug in such a
                                                                                                                                manner to allow a reduction in dosing
                                                                                                                                frequency as compared to that drug (or
                                                                                                                                drugs) presented as a conventional dosage
                                                                                                                                form.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42932   FILM                               A thin layer or coating.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42920   FILM, EXTENDED RELEASE             A drug delivery system in the form of a film FILM ER
                                                                                                                                that releases the drug over an extended
                                                                                                                                period in such a way as to maintain constant
                                                                                                                                drug levels in the blood or target tissue.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42984   FILM, SOLUBLE                      A thin layer or coating which is susceptible        FILM SOLUBLE
                                                                                                                                to being dissolved when in contact with a
                                                                                                                                liquid.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60927   FOR SOLUTION                       A product, usually a solid, intended for            FOR SOL
                                                                                                                                solution prior to administration.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60928   FOR SUSPENSION                     A product, usually a solid, intended for            FOR SUSP
                                                                                                                                suspension prior to administration.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60929   FOR SUSPENSION, EXTENDED RELEASE   A product, usually a solid, intended for            FOR SUSP ER
                                                                                                                                suspension prior to administration; once the
                                                                                                                                suspension is administered, the drug will be
                                                                                                                                released at a constant rate over a specified
                                                                                                                                period.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42933   GAS                                Any elastic aeriform fluid in which the             GAS
                                                                                                                                molecules are separated from one another
                                                                                                                                and have free paths.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42934   GEL                                A semisolid (1) dosage form that contains a         GEL
                                                                                                                                gelling agent to provide stiffness to a
                                                                                                                                solution or a colloidal dispersion (2). A gel
                                                                                                                                may contain suspended particles. Note 1: A
                                                                                                                                semisolid is not pourable; it does not flow or
                                                                                                                                conform to its container at room
                                                                                                                                temperature. It does not flow at low shear
                                                                                                                                stress and generally exhibits plastic flow
                                                                                                                                behavior. Note 2: A colloidal dispersion is a
                                                                                                                                system in which particles of colloidal
                                                                                                                                dimension (i.e., typically between 1 nm and
                                                                                                                                1 micrometer) are distributed uniformly
                                                                                                                                throughout a liquid.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42906   GEL, DENTIFRICE                    A combination of a dentifrice (formulation          GEL DENT
                                                                                                                                intended to clean and/or polish the teeth,
                                                                                                                                and which may contain certain additional
                                                                                                                                agents), and a gel. It is used with a
                                                                                                                                toothbrush for the purpose of cleaning and
                                                                                                                                polishing the teeth.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60930   GEL, METERED                       A gel preparation, with metered dose valves,        GEL MET
                                                                                                                                which allow for the delivery of a uniform
                                                                                                                                quantity of gel upon each activation.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C48193   GENERATOR                                        An apparatus for the formation of vapor or     GENERATOR
                                                                                                                                              gas from a liquid or solid by heat or chemical
                                                                                                                                              action. The term GENERATOR also applies
                                                                                                                                              to radioactive columns from which
                                                                                                                                              radionuclides are provided.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42937   GLOBULE                                          Also called pellets or pilules, are made of
                                                                                                                                              pure sucrose, lactose, or other
                                                                                                                                              polysaccharides. They are formed into small
                                                                                                                                              globular masses of various sizes, and are
                                                                                                                                              medicated by placing them in a vial and
                                                                                                                                              adding the liquid drug attenuation in the
                                                                                                                                              proportion not less than one percent (v/w).
                                                                                                                                              After shaking, the medicated globules are
                                                                                                                                              dried at temperatures not to exceed 40
                                                                                                                                              degrees Centigrade.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C45416   GRAFT                                  A slip of skin or of other tissue for
                                                                                                                                    implantation.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42938   GRANULE                                A small particle or grain.                            GRAN
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42903   GRANULE, DELAYED RELEASE               A small medicinal particle or grain to which          GRAN DR
                                                                                                                                    an enteric or other coating has been applied,
                                                                                                                                    thus delaying release of the drug until its
                                                                                                                                    passage into the intestines.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42909   GRANULE, EFFERVESCENT                  A small particle or grain containing a                GRAN EFFRV
                                                                                                                                    medicinal agent in a dry mixture usually
                                                                                                                                    composed of sodium bicarbonate, citric acid,
                                                                                                                                    and tartaric acid which, when in contact with
                                                                                                                                    water, has the capability to release gas,
                                                                                                                                    resulting in effervescence.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42939   GRANULE, FOR SOLUTION                  A small medicinal particle or grain made              GRAN F/SOL
                                                                                                                                    available in its more stable dry form, to be
                                                                                                                                    reconstituted with solvent just before
                                                                                                                                    dispensing; the granules are so prepared to
                                                                                                                                    contain not only the medicinal agent, but the
                                                                                                                                    colorants, flavorants, and any other desired
                                                                                                                                    pharmaceutic ingredient.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42940   GRANULE, FOR SUSPENSION                A small medicinal particle or grain made              GRAN F/SUS
                                                                                                                                    available in its more stable dry form, to be
                                                                                                                                    reconstituted with solvent just before
                                                                                                                                    dispensing to form a suspension; the
                                                                                                                                    granules are so prepared to contain not only
                                                                                                                                    the medicinal agent, but the colorants,
                                                                                                                                    flavorants, and any other desired
                                                                                                                                    pharmaceutic ingredient.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42921                                          A small medicinal particle or grain made
                                                                                             GRANULE, FOR SUSPENSION, EXTENDED RELEASE                                                    GRAN F/SUSP ER
                                                                                                                                    available in its more stable dry form, to be
                                                                                                                                    reconstituted with solvent just before
                                                                                                                                    dispensing to form a suspension; the
                                                                                                                                    extended release system achieves slow
                                                                                                                                    release of the drug over an extended period
                                                                                                                                    of time and maintains constant drug levels in
                                                                                                                                    the blood or target tissue.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42941   GUM                                    A mucilaginous excretion from various
                                                                                                                                    plants.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42894   GUM, CHEWING                           A sweetened and flavored insoluble plastic            GUM CHEWING
                                                                                                                                    material of various shapes which when
                                                                                                                                    chewed, releases a drug substance into the
                                                                                                                                    oral cavity.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42978   GUM, RESIN                             Natural mixture of gum and resin, usually             GUM RESIN
                                                                                                                                    obtained as exudations from plants.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42942   IMPLANT                                                                                      IMP
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42944   INHALANT                               A special class of inhalations consisting of a
                                                                                                                                    drug or combination of drugs, that by virtue
                                                                                                                                    of their high vapor pressure, can be carried
                                                                                                                                    by an air current into the nasal passage
                                                                                                                                    where they exert their effect; the container
                                                                                                                                    from which the inhalant generally is
                                                                                                                                    administered is known as an inhaler.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60931   INJECTABLE, LIPOSOMAL                    An injection, which either consists of or           INJ LIPOS
                                                                                                                                      forms liposomes (a lipid bilayer vesicle
                                                                                                                                      usually composed of phospholipids which is
                                                                                                                                      used to encapsulate an active drug
                                                                                                                                      substance).
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42946   INJECTION                                A sterile preparation intended for parenteral       INJ
                                                                                                                                      use; five distinct classes of injections exist as
                                                                                                                                      defined by the USP.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42914   INJECTION, EMULSION                      An emulsion consisting of a sterile, pyrogen-       INJ EMULSION
                                                                                                                                      free preparation intended to be administered
                                                                                                                                      parenterally.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42950   INJECTION, LIPID COMPLEX                 [definition pending]                                INJ LIPID COMPLEX
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42974   INJECTION, POWDER, FOR SOLUTION          A sterile preparation intended for                  INJ PWD F/SOL
                                                                                                                                      reconstitution to form a solution for
                                                                                                                                      parenteral use.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42976   INJECTION, POWDER, FOR SUSPENSION        A sterile preparation intended for                  INJ PWD F/SUSP
                                                                                                                                      reconstitution to form a suspension for
                                                                                                                                      parenteral use.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42977                                            A dried preparation intended for
                                                                                             INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE                                          INJ PWD F/SUSP ER
                                                                                                                                      reconstitution to form a suspension for
                                                                                                                                      parenteral use which has been formulated in
                                                                                                                                      a manner to allow at least a reduction in
                                                                                                                                      dosing frequency as compared to that drug
                                                                                                                                      presented as a conventional dosage form
                                                                                                                                      (e.g., as a solution).
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42959                                            A sterile freeze dried
                                                                                             INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSIONpreparation intended                 INJ PWD LYO F/LS
                                                                                                                                      for reconstitution for parenteral use which
                                                                                                                                      has been formulated in a manner that would
                                                                                                                                      allow liposomes (a lipid bilayer vesicle
                                                                                                                                      usually composed of phospholipids which is
                                                                                                                                      used to encapsulate an active drug
                                                                                                                                      substance, either within a lipid bilayer or in
                                                                                                                                      an aqueous space) to be formed upon
                                                                                                                                      reconstitution.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42957                                            A dosage form intended for the solution
                                                                                             INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION                                             INJ PWD LYO F/SOL
                                                                                                                                      prepared by lyophilization ('freeze drying'), a
                                                                                                                                      process which involves the removal of water
                                                                                                                                      from products in the frozen state at
                                                                                                                                      extremely low pressures; this is intended for
                                                                                                                                      subsequent addition of liquid to create a
                                                                                                                                      solution that conforms in all respects to the
                                                                                                                                      requirements for Injections.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42958                                            A liquid
                                                                                             INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION preparation, intended for parenteral INJ PWD LYO F/SUSP
                                                                                                                                      use, that contains solids suspended in a
                                                                                                                                      suitable fluid medium and conforms in all
                                                                                                                                      respects to the requirements for Sterile
                                                                                                                                      Suspensions; the medicinal agents intended
                                                                                                                                      for the suspension are prepared by
                                                                                                                                      lyophilization ("freeze drying"), a process
                                                                                                                                      which involves the removal of water from
                                                                                                                                      products in the frozen state at extremely low
                                                                                                                                      pressures.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42956                                            A sterile EXTENDED RELEASE
                                                                                             INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, freeze dried preparation intended    INJ PWD LYO F/SUSPER
                                                                                                                                      for reconstitution for parenteral use which
                                                                                                                                      has been formulated in a manner to allow at
                                                                                                                                      least a reduction in dosing frequency as
                                                                                                                                      compared to that drug presented as a
                                                                                                                                      conventional dosage form (e.g., as a
                                                                                                                                      solution).
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42945   INJECTION, SOLUTION                      A liquid preparation containing one or more INJ SOL
                                                                                                                                      drug substances dissolved in a suitable
                                                                                                                                      solvent or mixture of mutually miscible
                                                                                                                                      solvents that is suitable for injection.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42899   INJECTION, SOLUTION, CONCENTRATE             A sterile preparation for parenteral use            INJ SOL CONC
                                                                                                                                          which, upon the addition of suitable
                                                                                                                                          solvents, yields a solution conforming in all
                                                                                                                                          respects to the requirements for Injections.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42995   INJECTION, SUSPENSION                        A liquid preparation, suitable for injection,       INJ SUSP
                                                                                                                                          which consists of solid particles dispersed
                                                                                                                                          throughout a liquid phase in which the
                                                                                                                                          particles are not soluble. It can also consist
                                                                                                                                          of an oil phase dispersed throughout an
                                                                                                                                          aqueous phase, or vice-versa.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42926   INJECTION, SUSPENSION, EXTENDED RELEASE A sterile preparation intended for parenteral INJ SUSP ER
                                                                                                                                     use which has been formulated in a manner
                                                                                                                                     to allow at least a reduction in dosing
                                                                                                                                     frequency as compared to that drug
                                                                                                                                     presented as a conventional dosage form
                                                                                                                                     (e.g., as a solution or a prompt drug-
                                                                                                                                     releasing, conventional solid dosage form).

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42951   INJECTION, SUSPENSION, LIPOSOMAL             A liquid preparation, suitable for injection,  INJ SUSP LIPOS
                                                                                                                                          which consists of an oil phase dispersed
                                                                                                                                          throughout an aqueous phase in such a
                                                                                                                                          manner that liposomes (a lipid bilayer vesicle
                                                                                                                                          usually composed of phospholipids which is
                                                                                                                                          used to encapsulate an active drug
                                                                                                                                          substance, either within a lipid bilayer or in
                                                                                                                                          an aqueous space) are formed.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42988   INJECTION, SUSPENSION, SONICATED             A liquid preparation, suitable for injection,  INJ SUSP SON
                                                                                                                                          which consists of solid particles dispersed
                                                                                                                                          throughout a liquid phase in which the
                                                                                                                                          particles are not soluble. In addition, the
                                                                                                                                          product is sonicated while a gas is bubbled
                                                                                                                                          through the suspension, and this results in
                                                                                                                                          the formation of microspheres by the solid
                                                                                                                                          particles.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60933   INSERT                                       A specially formulated and shaped non-         INSERT
                                                                                                                                          encapsulated solid preparation intended to
                                                                                                                                          be placed into a non-rectal orifice of the
                                                                                                                                          body, where drug is released, generally for
                                                                                                                                          localized effects.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42922   INSERT, EXTENDED RELEASE                     A specially formulated and shaped non-         INSERT ER
                                                                                                                                          encapsulated solid preparation intended to
                                                                                                                                          be placed into a non-rectal orifice of the
                                                                                                                                          body, where the medication is released,
                                                                                                                                          generally for localized effects; the extended
                                                                                                                                          release preparation is designed to allow for a
                                                                                                                                          reduction in dosing frequency.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47915   INTRAUTERINE DEVICE                          A device inserted and left in the uterus to   IUD
                                                                                                                                          prevent effective conception.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42947   IRRIGANT                                     A sterile solution intended to bathe or flush
                                                                                                                                          open wounds or body cavities; they're used
                                                                                                                                          topically, never parenterally.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42948   JELLY                                        A class of gels--semisolid systems which      JELLY
                                                                                                                                          consist of suspensions made up of either
                                                                                                                                          small inorganic particles or large organic
                                                                                                                                          molecules interpenetrated by a liquid--in
                                                                                                                                          which the structural coherent matrix contains
                                                                                                                                          a high portion of liquid, usually water.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47916   KIT                                          A packaged collection of related material.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C45413   LINER, DENTAL                                A material applied to the inside of the dental LINER DENTAL
                                                                                                                                          cavity, for protection or insulation of the
                                                                                                                                          surface.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42949   LINIMENT                                     A solution or mixture of various substances
                                                                                                                                          in oil, alcoholic solutions of soap, or
                                                                                                                                          emulsions intended for external application.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42952   LIPSTICK                                     A waxy solid, usually colored cosmetic, in
                                                                                                                                          stick form for the lips.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42953   LIQUID                                       A dosage form consisting of a pure chemical LIQ
                                                                                                                                          in its liquid state. This dosage form term
                                                                                                                                          should not be applied to solutions. Note: A
                                                                                                                                          liquid is pourable; it flows and conforms to its
                                                                                                                                          container at room temperature. It displays
                                                                                                                                          Newtonian or pseudoplastic flow behavior.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60934   LIQUID, EXTENDED RELEASE                     A liquid that delivers a drug in such a          LIQ ER
                                                                                                                                          manner to allow a reduction in dosing
                                                                                                                                          frequency as compared to that drug (or
                                                                                                                                          drugs) presented as a conventional dosage
                                                                                                                                          form.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C29167   LOTION                                       An emulsion, liquid (1) dosage form. This        LOTION
                                                                                                                                          dosage form is generally for external
                                                                                                                                          application to the skin (2). Note 1: A liquid is
                                                                                                                                          pourable; it flows and conforms to its
                                                                                                                                          container at room temperature. It displays
                                                                                                                                          Newtonian or pseudoplastic flow behavior.
                                                                                                                                          Note 2: Previously the definition of a lotion
                                                                                                                                          was: The term lotion has been used to
                                                                                                                                          categorize many topical suspensions,
                                                                                                                                          solutions, and emulsions intended for
                                                                                                                                          application to the skin. The current definition
                                                                                                                                          of a lotion is restricted to an emulsion.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60957   LOTION, AUGMENTED                            A lotion dosage form that enhances drug             LOTION AUG
                                                                                                                                          delivery. Augmentation does not refer to the
                                                                                                                                          strength of the drug in the dosage form.
                                                                                                                                          NOTE: CDER has decided to refrain from
                                                                                                                                          expanding the use of this dosage form due
                                                                                                                                          to difficulties in setting specific criteria that
                                                                                                                                          must be met to be considered augmented.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60958   LOTION/SHAMPOO                               A lotion dosage form which has a soap or            LOTION SHAMPOO
                                                                                                                                          detergent that is usually used to clean the
                                                                                                                                          hair and scalp; it is often used as a vehicle
                                                                                                                                          for dermatologic agents.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42955   LOZENGE                                      A solid preparation containing one or more          LOZENGE
                                                                                                                                          medicaments, usually in a flavored,
                                                                                                                                          sweetened base which is intended to
                                                                                                                                          dissolve or disintegrate slowly in the mouth.
                                                                                                                                          A lollipop is a lozenge on a stick.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C29269   MOUTHWASH                                An aqueous solution which is most often            MOUTHWASH
                                                                                                                                      used for its deodorant, refreshing, or
                                                                                                                                      antiseptic effect.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C48624   NOT APPLICABLE                           The use of a dosage form term is not               NOT APPLICABLE
                                                                                                                                      relevant or appropriate.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42965   OIL                                      An unctuous, combustible substance which           OIL
                                                                                                                                      is liquid, or easily liquefiable, on warming,
                                                                                                                                      and is soluble in ether but insoluble in water.
                                                                                                                                      Such substances, depending on their origin,
                                                                                                                                      are classified as animal, mineral, or
                                                                                                                                      vegetable oils.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42966   OINTMENT                                 A semisolid (1) dosage form, usually               OINTMENT
                                                                                                                                      containing <20% water and volatiles (2) and
                                                                                                                                      >50% hydrocarbons, waxes, or polyols as
                                                                                                                                      the vehicle. This dosage form is generally for
                                                                                                                                      external application to the skin or mucous
                                                                                                                                      membranes. Note 1: A semisolid is not
                                                                                                                                      pourable; it does not flow or conform to its
                                                                                                                                      container at room temperature. It does not
                                                                                                                                      flow at low shear stress and generally
                                                                                                                                      exhibits plastic flow behavior. Note 2:
                                                                                                                                      Percent water and volatiles are measured by
                                                                                                                                      a loss on drying test in which the sample is
                                                                                                                                      heated at 105 degrees C until constant
                                                                                                                                      weight is achieved.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60984   OINTMENT, AUGMENTED                      An ointment dosage form that enhances              OINTMENT AUG
                                                                                                                                      drug delivery. Augmentation does not refer
                                                                                                                                      to the strength of the drug in the dosage
                                                                                                                                      form. NOTE: CDER has decided to refrain
                                                                                                                                      from expanding the use of this dosage form
                                                                                                                                      due to difficulties in setting specific criteria
                                                                                                                                      that must be met to be considered
                                                                                                                                      augmented.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47887   PACKING                                  A material, usually covered by or                  PACKING
                                                                                                                                      impregnated with a drug, that is inserted into
                                                                                                                                      a body cavity or between the tooth enamel
                                                                                                                                      and the gingival margin.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42967   PASTE                                    A semisolid dosage form, containing a large
                                                                                                                                      proportion (20 - 50%) of solids finely
                                                                                                                                      dispersed in a fatty vehicle. This dosage
                                                                                                                                      form is generally for external application to
                                                                                                                                      the skin or mucous membranes. Note: A
                                                                                                                                      semisolid is not pourable; it does not flow or
                                                                                                                                      conform to its container at room
                                                                                                                                      temperature. It does not flow at low shear
                                                                                                                                      stress and generally exhibits plastic flow
                                                                                                                                      behavior.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42907   PASTE, DENTIFRICE                        A paste formulation intended to clean and/or       PASTE DENT
                                                                                                                                      polish the teeth, and which may contain
                                                                                                                                      certain additional agents.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60985   PASTILLE                                 An aromatic preparation, often with a              PASTILLE
                                                                                                                                      pleasing flavor, usually intended to dissolve
                                                                                                                                      in the mouth.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42968   PATCH                                    A drug delivery system that often contains         PATCH
                                                                                                                                      an adhesive backing that is usually applied
                                                                                                                                      to an external site on the body. Its
                                                                                                                                      ingredients either passively diffuse from, or
                                                                                                                                      are actively transported from, some portion
                                                                                                                                      of the patch. Depending upon the patch,
                                                                                                                                      the ingredients are either delivered to the
                                                                                                                                      outer surface of the body or into the body. A
                                                                                                                                      patch is sometimes synonymous with the
                                                                                                                                      terms Extended Release Film and System.


FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42923   PATCH, EXTENDED RELEASE                  A drug delivery system in the form of a patch PATCH ER
                                                                                                                                      that releases the drug in such a manner that
                                                                                                                                      a reduction in dosing frequency compared to
                                                                                                                                      that drug presented as a conventional
                                                                                                                                      dosage form (e.g., a solution or a prompt
                                                                                                                                      drug-releasing, conventional solid dosage
                                                                                                                                      form).

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42911                                           A drug delivery
                                                                                             PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED system in the form of a patch PATCH ER ELCON
                                                                                                                                     which is controlled by an electric current that
                                                                                                                                     releases the drug in such a manner that a
                                                                                                                                     reduction in dosing frequency compared to
                                                                                                                                     that drug presented as a conventional
                                                                                                                                     dosage form (e.g., a solution or a prompt
                                                                                                                                     drug-releasing, conventional solid dosage
                                                                                                                                     form).

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42969   PELLET                                   A small sterile solid mass consisting of a         PELLET
                                                                                                                                      highly purified drug (with or without
                                                                                                                                      excipients) made by the formation of
                                                                                                                                      granules, or by compression and molding.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42943   PELLET, IMPLANTABLE                      A small sterile solid mass consisting of a         PELLET IMP
                                                                                                                                      highly purified drug (with or without
                                                                                                                                      excipients) made by the formation of
                                                                                                                                      granules, or by compression and molding;
                                                                                                                                      they are intended for implantation in the
                                                                                                                                      body (usually subcutaneously) for the
                                                                                                                                      purpose of providing continuous release of
                                                                                                                                      the drug over long periods of time.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42918   PELLETS, COATED, EXTENDED RELEASE        A solid dosage form in which the drug itself       PELLETS COATED ER
                                                                                                                                      is in the form of granules to which varying
                                                                                                                                      amounts of coating have been applied, and
                                                                                                                                      which releases a drug (or drugs) in such a
                                                                                                                                      manner to allow a reduction in dosing
                                                                                                                                      frequency as compared to that drug (or
                                                                                                                                      drugs) presented as a conventional dosage
                                                                                                                                      form
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42636   PHARMACEUTICAL DOSAGE FORM
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C25394   PILL                                     A small, round solid dosage form containing PILL
                                                                                                                                      a medicinal agent intended for oral
                                                                                                                                      administration.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42970   PLASTER                                  Substance intended for external application
                                                                                                                                      made of such materials and of such
                                                                                                                                      consistency as to adhere to the skin and
                                                                                                                                      attach to a dressing; plasters are intended to
                                                                                                                                      afford protection and support and/or to
                                                                                                                                      furnish an occlusion and macerating action
                                                                                                                                      and to bring medication into close contact
                                                                                                                                      with the skin.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47913   POULTICE                                 A soft, moist mass of meal, herbs, seed,         POULTICE
                                                                                                                                      etc., usually applied hot in cloth that consists
                                                                                                                                      of gruel-like consistency.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42972   POWDER                                   An intimate mixture of dry, finely divided       PWD
                                                                                                                                      drugs and/or chemicals that may be
                                                                                                                                      intended for internal or external use.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42908   POWDER, DENTIFRICE                       A powder formulation intended to clean           PWD DENT
                                                                                                                                      and/or polish the teeth, and which may
                                                                                                                                      contain certain additional agents.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42973   POWDER, FOR SOLUTION                          An intimate mixture of dry, finely divided         PWD F/SOL
                                                                                                                                           drugs and/or chemicals, which, upon the
                                                                                                                                           addition of suitable vehicles, yields a
                                                                                                                                           solution.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42975   POWDER, FOR SUSPENSION                        An intimate mixture of dry, finely divided         PWD F/SUSP
                                                                                                                                           drugs and/or chemicals, which, upon the
                                                                                                                                           addition of suitable vehicles, yields a
                                                                                                                                           suspension (a liquid preparation containing
                                                                                                                                           the solid particles dispersed in the liquid
                                                                                                                                           vehicle).
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42961   POWDER, METERED                               A powder dosage form that is situated inside       PWD MET
                                                                                                                                           a container that has a mechanism to deliver
                                                                                                                                           a specified quantity.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60988   RING                                          A small circular object with a vacant circular     RING
                                                                                                                                           center that is usually intended to be placed
                                                                                                                                           in the body by special inserters, where the
                                                                                                                                           medication is released, generally for
                                                                                                                                           localized effects.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42979   RINSE                                         A liquid used to cleanse by flushing.              RINSE
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42980   SALVE                                         A thick ointment or cerate (a fat or wax           SALVE
                                                                                                                                           based preparation with a consistency
                                                                                                                                           between an ointment and a plaster).
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42981   SHAMPOO                                       A liquid soap or detergent used to clean the       SHAMPOO
                                                                                                                                           hair and scalp and is often used as a vehicle
                                                                                                                                           for dermatologic agents.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42982   SHAMPOO, SUSPENSION                           A liquid soap or detergent containing one or       SHAMPOO SUSP
                                                                                                                                           more solid, insoluble substances dispersed
                                                                                                                                           in a liquid vehicle that is used to clean the
                                                                                                                                           hair and scalp and is often used as a vehicle
                                                                                                                                           for dermatologic agents.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42983   SOAP                                          Any compound of one or more fatty acids, or SOAP
                                                                                                                                           their equivalents, with an alkali; soap is
                                                                                                                                           detergent and is much employed in
                                                                                                                                           liniments, enemas, and in making pills. It is
                                                                                                                                           also a mild aperient, antacid and antiseptic.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42986   SOLUTION                                      A clear, homogeneous liquid dosage form       SOL
                                                                                                                                           that contains one or more chemical
                                                                                                                                           substances dissolved in a solvent or mixture
                                                                                                                                           of mutually miscible solvents. Note: A liquid
                                                                                                                                           is pourable; it flows and conforms to its
                                                                                                                                           container at room temperature. It displays
                                                                                                                                           Newtonian or pseudoplastic flow behavior.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42898   SOLUTION, CONCENTRATE                  A liquid preparation (i.e., a substance that      SOL CONC
                                                                                                                                    flows readily in its natural state) that contains
                                                                                                                                    a drug dissolved in a suitable solvent or
                                                                                                                                    mixture of mutually miscible solvents; the
                                                                                                                                    drug has been strengthened by the
                                                                                                                                    evaporation of its non-active parts.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42987   SOLUTION, FOR SLUSH                    A solution for the preparation of an iced         SOL F/SLUSH
                                                                                                                                    saline slush, which is administered by
                                                                                                                                    irrigation and used to induce regional
                                                                                                                                    hypothermia (in conditions such as certain
                                                                                                                                    open heart and kidney surgical procedures)
                                                                                                                                    by its direct application.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42935   SOLUTION, GEL FORMING, EXTENDED RELEASEA solution that forms a gel when it comes in SOL GF ER
                                                                                                                                    contact with ocular fluid, and which allows at
                                                                                                                                    least a reduction in dosing frequency

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60994   SOLUTION, GEL FORMING/DROPS                   A solution, which after usually being              SOL GF DROPS
                                                                                                                                           administered in a drop-wise fashion, forms a
                                                                                                                                           gel.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60992   SOLUTION/DROPS                                A solution which is usually administered in a      SOL DROPS
                                                                                                                                           drop-wise fashion.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47912   SPONGE                                        A porous, interlacing, absorbent material          SPONGE
                                                                                                                                           that contains a drug. It is typically used for
                                                                                                                                           applying or introducing medication, or for
                                                                                                                                           cleansing. A sponge usually retains its
                                                                                                                                           shape.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42989   SPRAY                                         A liquid minutely divided as by a jet of air or
                                                                                                                                           steam.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42962   SPRAY, METERED                                A non-pressurized dosage form consisting of        SPRAY MET
                                                                                                                                           valves which allow the dispensing of a
                                                                                                                                           specified quantity of spray upon each
                                                                                                                                           activation.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42990   SPRAY, SUSPENSION                             A liquid preparation containing solid particles    SPRAY SUSP
                                                                                                                                           dispersed in a liquid vehicle and in the form
                                                                                                                                           of coarse droplets or as finely divided solids
                                                                                                                                           to be applied locally, most usually to the
                                                                                                                                           nasal-pharyngeal tract, or topically to the
                                                                                                                                           skin.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42991   STICK                                         A dosage form prepared in a relatively long        STICK
                                                                                                                                           and slender often cylindrical form.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47914   STRIP                                         A long narrow piece of material.                   STRIP
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42993   SUPPOSITORY                                   A solid body of various weights and shapes,        SUPP
                                                                                                                                           adapted for introduction into the rectal orifice
                                                                                                                                           of the human body; they usually melt,
                                                                                                                                           soften, or dissolve at body temperature.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42924   SUPPOSITORY, EXTENDED RELEASE                 A drug delivery system in the form of a        SUPP ER
                                                                                                                                           suppository that allows for a reduction in
                                                                                                                                           dosing frequency.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42994   SUSPENSION                                    A liquid dosage form that contains solid       SUSP
                                                                                                                                           particles dispersed in a liquid vehicle. Note:
                                                                                                                                           A liquid is pourable; it flows and conforms to
                                                                                                                                           its container at room temperature. It displays
                                                                                                                                           Newtonian or pseudoplastic flow behavior.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42925   SUSPENSION, EXTENDED RELEASE                  A liquid preparation consisting of solid      SUSP ER
                                                                                                                                           particles dispersed throughout a liquid
                                                                                                                                           phase in which the particles are not soluble;
                                                                                                                                           the suspension has been formulated in a
                                                                                                                                           manner to allow at least a reduction in
                                                                                                                                           dosing frequency as compared to that drug
                                                                                                                                           presented as a conventional dosage form
                                                                                                                                           (e.g., as a solution or a prompt drug-
                                                                                                                                           releasing, conventional solid dosage form).

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60995   SUSPENSION/DROPS                              A suspension which is usually administered SUSP DROPS
                                                                                                                                           in a dropwise fashion.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47889   SUTURE                                        A strand or fiber used to hold wound edges
                                                                                                                                           in apposition during healing.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47898   SWAB                                          A small piece of relatively flat absorbent
                                                                                                                                           material that contains a drug. A swab may
                                                                                                                                           also be attached to one end of a small stick.
                                                                                                                                           A swab is typically used for applying
                                                                                                                                           medication or for cleansing.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42996   SYRUP                                         An oral solution containing high              SYRUP
                                                                                                                                           concentrations of sucrose or other sugars;
                                                                                                                                           the term has also been used to include any
                                                                                                                                           other liquid dosage form prepared in a sweet
                                                                                                                                           and viscid vehicle, including oral
                                                                                                                                           suspensions.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42998   TABLET                                        A solid dosage form containing medicinal      TAB
                                                                                                                                           substances with or without suitable diluents.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42893   TABLET, CHEWABLE                              A solid dosage form containing medicinal      TAB CHEW
                                                                                                                                           substances with or without suitable diluents
                                                                                                                                           that is intended to be chewed, producing a
                                                                                                                                           pleasant tasting residue in the oral cavity
                                                                                                                                           that is easily swallowed and does not leave a
                                                                                                                                           bitter or unpleasant after-taste.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42897   TABLET, COATED                                A solid dosage form that contains medicinal      TAB COATED
                                                                                                                                           substances with or without suitable diluents
                                                                                                                                           and is covered with a designated coating.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C60997   TABLET, COATED PARTICLES                      A solid dosage form containing a               TAB COATED PART
                                                                                                                                           conglomerate of medicinal particles that
                                                                                                                                           have each been covered with a coating.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42905   TABLET, DELAYED RELEASE                       A solid dosage form which releases a drug      TAB DR
                                                                                                                                           (or drugs) at a time other than promptly after
                                                                                                                                           administration. Enteric-coated articles are
                                                                                                                                           delayed release dosage forms.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42997   TABLET, DELAYED RELEASE PARTICLES             A solid dosage form containing a             TAB DR PARTICLES
                                                                                                                                           conglomerate of medicinal particles that
                                                                                                                                           have been covered with a coating which
                                                                                                                                           releases a drug (or drugs) at a time other
                                                                                                                                           than promptly after administration. Enteric-
                                                                                                                                           coated articles are delayed release dosage
                                                                                                                                           forms.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42910   TABLET, EFFERVESCENT                          A solid dosage form containing mixtures of TAB EFFRV
                                                                                                                                           acids (e.g., citric acid, tartaric acid) and
                                                                                                                                           sodium bicarbonate, which release carbon
                                                                                                                                           dioxide when dissolved in water; it is
                                                                                                                                           intended to be dissolved or dispersed in
                                                                                                                                           water before administration.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42927   TABLET, EXTENDED RELEASE                      A solid dosage form containing a drug which TAB ER
                                                                                                                                           allows at least a reduction in dosing
                                                                                                                                           frequency as compared to that drug
                                                                                                                                           presented in conventional dosage form.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42931   TABLET, FILM COATED                           A solid dosage form that contains medicinal      TAB FILM COATED
                                                                                                                                           substances with or without suitable diluents
                                                                                                                                           and is coated with a thin layer of a water-
                                                                                                                                           insoluble or water-soluble polymer.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42930   TABLET, FILM COATED, EXTENDED RELEASE         A solid dosage form that contains medicinal TAB FILM COATED ER
                                                                                                                                           substances with or without suitable diluents
                                                                                                                                           and is coated with a thin layer of a water-
                                                                                                                                           insoluble or water-soluble polymer; the tablet
                                                                                                                                           is formulated in such manner as to make the
                                                                                                                                           contained medicament available over an
                                                                                                                                           extended period of time following ingestion.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C61004   TABLET, FOR SOLUTION                          A tablet that forms a solution when placed in TAB FOR SOL
                                                                                                                                           a liquid.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C61005   TABLET, FOR SUSPENSION                        A tablet that, prior to administration, is    TAB DISP|TAB FOR SUSP|TABLET, FOR SUSPENSION
                                                                                                                                           intended to be placed in liquid, where its
                                                                                                                                           contents will be distributed evenly
                                                                                                                                           throughout that liquid. Note: The term
                                                                                                                                           Tablet, Dispersible is no longer used for
                                                                                                                                           approved drug products, and it has been
                                                                                                                                           replaced by the term tablet, for suspension.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42964   TABLET, MULTILAYER                            A solid dosage form containing medicinal         TAB MULTILAYER
                                                                                                                                           substances that have been compressed to
                                                                                                                                           form a multiple-layered tablet or a tablet-
                                                                                                                                           within-a-tablet, the inner tablet being the
                                                                                                                                           core and the outer portion being the shell.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42963   TABLET, MULTILAYER, EXTENDED RELEASE     A solid dosage form containing medicinal              TAB MULTILAYER ER
                                                                                                                                      substances that have been compressed to
                                                                                                                                      form a multiple-layered tablet or a tablet-
                                                                                                                                      within-a-tablet, the inner tablet being the
                                                                                                                                      core and the outer portion being the shell,
                                                                                                                                      which, additionally, is covered in a
                                                                                                                                      designated coating; the tablet is formulated
                                                                                                                                      in such manner as to allow at least a
                                                                                                                                      reduction in dosing frequency as compared
                                                                                                                                      to that drug presented as a conventional
                                                                                                                                      dosage form.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42999   TABLET, ORALLY DISINTEGRATING            A solid dosage form containing medicinal              TAB ORALLY DIS
                                                                                                                                      substances which disintegrates rapidly,
                                                                                                                                      usually within a matter of seconds, when
                                                                                                                                      placed upon the tongue.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C61006                                            A solid dosage form containing medicinal
                                                                                             TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE                                                 TAB ORALLY DIS DR
                                                                                                                                      substances which disintegrates rapidly,
                                                                                                                                      usually within a matter of seconds, when
                                                                                                                                      placed upon the tongue, but which releases
                                                                                                                                      a drug (or drugs) at a time other than
                                                                                                                                      promptly after administration.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42985   TABLET, SOLUBLE                          A solid dosage form that contains medicinal           TAB SOLUBLE
                                                                                                                                      substances with or without suitable diluents
                                                                                                                                      and possesses the ability to dissolve in
                                                                                                                                      fluids.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C42992   TABLET, SUGAR COATED                     A solid dosage form that contains medicinal           TAB SUGAR COATED
                                                                                                                                      substances with or without suitable diluents
                                                                                                                                      and is coated with a colored or an uncolored
                                                                                                                                      water-soluble sugar.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47892   TAMPON                                        A plug made of cotton, sponge, or oakum
                                                                                                                                           variously used in surgery to plug the nose,
                                                                                                                                           vagina, etc., for the control of hemorrhage or
                                                                                                                                           the absorption of secretions.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C47897   TAPE                                          A narrow woven fabric, or a narrow extruded
                                                                                                                                           synthetic (such as plastic), usually with an
                                                                                                                                           adhesive on one or both sides.

FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C43000   TINCTURE                                      An alcoholic or hydroalcoholic solution
                                                                                                                                           prepared from vegetable materials or from
                                                                                                                                           chemical substances.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C43001   TROCHE                                        A discoid-shaped solid containing the            TROCHE
                                                                                                                                           medicinal agent in a suitably flavored base;
                                                                                                                                           troches are placed in the mouth where they
                                                                                                                                           slowly dissolve, liberating the active
                                                                                                                                           ingredients.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C43002   UNASSIGNED                                    A dosage form has yet to be assigned.
FDA   C54456   Structured Product Labeling Pharmaceutical Dosage Form Terminology   C43003   WAFER                                         A thin slice of material containing a            WAFER
                                                                                                                                           medicinal agent.
FDA   C54458   Structured Product Labeling Potency Terminology                      C48472   ADJUST PH                                     LITERAL                                          ADJ PH
FDA   C54458   Structured Product Labeling Potency Terminology                      C48473   AMPULE                                        LITERAL                                          AMPULE
FDA   C54458   Structured Product Labeling Potency Terminology                      C62412   APPLICATOR                                    LITERAL                                          AP
FDA   C54458   Structured Product Labeling Potency Terminology                      C48474   BAG                                           LITERAL                                          BAG
FDA   C54458   Structured Product Labeling Potency Terminology                      C48475   BAR                                           LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology                      C53495   BEAD                                          LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology                      C54564   BLISTER                                       LITERAL                                          BLISTER
FDA   C54458   Structured Product Labeling Potency Terminology                      C61569   BLISTER PACK                                  LITERAL                                          BLPK
FDA   C54458   Structured Product Labeling Potency Terminology                      C53498   BLOCK                                         LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology                      C48476   BOLUS                                         LITERAL                                          BOL
FDA   C54458   Structured Product Labeling Potency Terminology                      C48477   BOTTLE                                        LITERAL                                          BOT
FDA   C54458   Structured Product Labeling Potency Terminology                      C48478   BOX                                           LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48479   CAN                               LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C62413   CANISTER                          LITERAL                                        CSTR
FDA   C54458   Structured Product Labeling Potency Terminology   C48480   CAPSULE                           LITERAL                                        CAP
FDA   C54458   Structured Product Labeling Potency Terminology   C48464   CAROTID SINUS RHYTHM UNITS        LITERAL                                        CSRU
FDA   C54458   Structured Product Labeling Potency Terminology   C54702   CARTON                            LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48481   CARTRIDGE                         LITERAL                                        CTG
FDA   C54458   Structured Product Labeling Potency Terminology   C62414   CASE                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C62274   CELLO PACK                        LITERAL                                        CELLO
FDA   C54458   Structured Product Labeling Potency Terminology   C48482   CLINICAL UNITS                    LITERAL                                        CU
FDA   C54458   Structured Product Labeling Potency Terminology   C48483   COAT                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48484   CONTAINER                         LITERAL                                        CTR
FDA   C54458   Structured Product Labeling Potency Terminology   C48485   COUNT                             LITERAL                                        CNT
FDA   C54458   Structured Product Labeling Potency Terminology   C48488   CUBIC INCH                        LITERAL                                        CU IN
FDA   C54458   Structured Product Labeling Potency Terminology   C54703   CUP                               LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48466   CURIE                             LITERAL                                        CI
FDA   C54458   Structured Product Labeling Potency Terminology   C48489   CYLINDER                          LITERAL                                        CYL
FDA   C54458   Structured Product Labeling Potency Terminology   C62415   DEWAR                             LITERAL                                        DEW
FDA   C54458   Structured Product Labeling Potency Terminology   C62416   DIALPACK                          LITERAL                                        DLPK
FDA   C54458   Structured Product Labeling Potency Terminology   C48490   DISK                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C62417   DOSE PACK                         LITERAL                                        DSPK
FDA   C54458   Structured Product Labeling Potency Terminology   C48491   DROPS                             LITERAL                                        DROPS
FDA   C54458   Structured Product Labeling Potency Terminology   C48492   DRUM                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48487   FEET, CUBIC                       LITERAL                                        CU FT
FDA   C54458   Structured Product Labeling Potency Terminology   C48461   FEET, SQUARE                      LITERAL                                        SQ FT
FDA   C54458   Structured Product Labeling Potency Terminology   C53499   FILM                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48493   FLUID DRAM                        LITERAL                                        FL DR
FDA   C54458   Structured Product Labeling Potency Terminology   C48494   FLUID OUNCE                       LITERAL                                        FL OZ
FDA   C54458   Structured Product Labeling Potency Terminology   C48580   GALLON                            LITERAL                                        GAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48496   GENERATOR                         LITERAL                                        GEN
FDA   C54458   Structured Product Labeling Potency Terminology   C48497   GRAIN                             LITERAL                                        GR
FDA   C54458   Structured Product Labeling Potency Terminology   C48155   GRAM                              LITERAL                                        GM
FDA   C54458   Structured Product Labeling Potency Terminology   C48498   HOMEOPATHIC DILUTION              LITERAL                                        X
FDA   C54458   Structured Product Labeling Potency Terminology   C25529   HOUR                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48499   IMPLANT                           LITERAL                                        IMP
FDA   C54458   Structured Product Labeling Potency Terminology   C48500   INCH                              LITERAL                                        IN
FDA   C54458   Structured Product Labeling Potency Terminology   C48501   INHALATION                        LITERAL                                        INH
FDA   C54458   Structured Product Labeling Potency Terminology   C62275   INHALER                           LITERAL                                        INHL
FDA   C54458   Structured Product Labeling Potency Terminology   C62418   INHALER, REFILL                   LITERAL                                        INHLRE
FDA   C54458   Structured Product Labeling Potency Terminology   C62276   INSERT                            LITERAL                                        INSERT
FDA   C54458   Structured Product Labeling Potency Terminology   C48579   INTERNATIONAL UNITS               LITERAL                                        IU
FDA   C54458   Structured Product Labeling Potency Terminology   C48502   JAR                               LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C62419   JUG                               LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48503   KALLIKREIN INHIBITOR UNIT         LITERAL                                        KIU
FDA   C54458   Structured Product Labeling Potency Terminology   C28252   KILOGRAM                          LITERAL                                        KG
FDA   C54458   Structured Product Labeling Potency Terminology   C48504   KIT                               LITERAL                                        KIT
FDA   C54458   Structured Product Labeling Potency Terminology   C48505   LITER                             LITERAL                                        L
FDA   C54458   Structured Product Labeling Potency Terminology   C48506   LOZENGE                           LITERAL                                        LOZ
FDA   C54458   Structured Product Labeling Potency Terminology   C48507   MICROCURIE                        LITERAL                                        UCI
FDA   C54458   Structured Product Labeling Potency Terminology   C48152   MICROGRAM                         LITERAL                                        UGM
FDA   C54458   Structured Product Labeling Potency Terminology   C48153   MICROLITER                        LITERAL                                        UL
FDA   C54458   Structured Product Labeling Potency Terminology   C48508   MICROMOLAR                        LITERAL                                        UMOLAR
FDA   C54458   Structured Product Labeling Potency Terminology   C48509   MICROMOLE                         LITERAL                                        UMOLE
FDA   C54458   Structured Product Labeling Potency Terminology   C48510   MICRON                            LITERAL                                        MCN
FDA   C54458   Structured Product Labeling Potency Terminology   C48511   MILLICURIE                        LITERAL                                        MCI
FDA   C54458   Structured Product Labeling Potency Terminology   C48512   MILLIEQUIVALENT                   LITERAL                                        MEQ
FDA   C54458   Structured Product Labeling Potency Terminology   C28253   MILLIGRAM                         LITERAL                                        MG
FDA   C54458   Structured Product Labeling Potency Terminology   C28254   MILLILITER                        LITERAL                                        ML
FDA   C54458   Structured Product Labeling Potency Terminology   C28251   MILLIMETER                        LITERAL                                        MM
FDA   C54458   Structured Product Labeling Potency Terminology   C48513   MILLIMOLE                         LITERAL                                        MMOLE
FDA   C54458   Structured Product Labeling Potency Terminology   C48514   MINIM                             LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48578   MISCELLANEOUS                     LITERAL                                        MISC
FDA   C54458   Structured Product Labeling Potency Terminology   C48555   MOLAR                             LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C42539   MOLE                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48516   NANOGRAM                          LITERAL                                        NGM
FDA   C54458   Structured Product Labeling Potency Terminology   C48517   NANOMOLE                          LITERAL                                        NMOLE
FDA   C54458   Structured Product Labeling Potency Terminology   C48554   NORMAL                            LITERAL                                        N
FDA   C54458   Structured Product Labeling Potency Terminology   C48587   NOT APPLICABLE                    LITERAL                                        N/A
FDA   C54458   Structured Product Labeling Potency Terminology   C48519   OUNCE                             LITERAL                                        OZ
FDA   C54458   Structured Product Labeling Potency Terminology   C48520   PACKAGE                           LITERAL                                        PKG
FDA   C54458   Structured Product Labeling Potency Terminology   C48521   PACKET                            LITERAL                                        PKT
FDA   C54458   Structured Product Labeling Potency Terminology   C48523   PART PER MILLION                  LITERAL                                        PPM
FDA   C54458   Structured Product Labeling Potency Terminology   C48522   PARTS                             LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48524   PATCH                             LITERAL                                        PATCH
FDA   C54458   Structured Product Labeling Potency Terminology   C48525   PELLET                            LITERAL                                        PEL
FDA   C54458   Structured Product Labeling Potency Terminology   C48570   PERCENT                           LITERAL                                        %
FDA   C54458   Structured Product Labeling Potency Terminology   C48571   PERCENT VOLUME/VOLUME             LITERAL                                        %V/V
FDA   C54458   Structured Product Labeling Potency Terminology   C48527   PERCENT WEIGHT/VOLUME             LITERAL                                        %W/V
FDA   C54458   Structured Product Labeling Potency Terminology   C48528   PERCENT WEIGHT/WEIGHT             LITERAL                                        %W/W
FDA   C54458   Structured Product Labeling Potency Terminology   C48588   POTENCY NOT GIVEN                 LITERAL                                        PNG
FDA   C54458   Structured Product Labeling Potency Terminology   C48470   POTENCY UNIT                      The basic quantity or increment used to
                                                                                                            describe the strength of a product or amount
                                                                                                            of product in a package.
FDA   C54458   Structured Product Labeling Potency Terminology   C48530   POUCH                             LITERAL                                        POUCH
FDA   C54458   Structured Product Labeling Potency Terminology   C48531   POUND                             LITERAL                                        LB
FDA   C54458   Structured Product Labeling Potency Terminology   C48532   PRESSOR UNITS                     LITERAL                                        PRU
FDA   C54458   Structured Product Labeling Potency Terminology   C48533   PROTEIN UNIT                      LITERAL                                        PNU
FDA   C54458   Structured Product Labeling Potency Terminology   C48590   QUANTITY SUFFICIENT               LITERAL                                        QS
FDA   C54458   Structured Product Labeling Potency Terminology   C48534   QUART                             LITERAL                                        QT
FDA   C54458   Structured Product Labeling Potency Terminology   C62609   RING                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48535   SATURATED                         LITERAL                                        SAT
FDA   C54458   Structured Product Labeling Potency Terminology   C48536   SCOOPFUL                          LITERAL                                        SCP
FDA   C54458   Structured Product Labeling Potency Terminology   C53502   SPONGE                            LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48537   SPRAY                             LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48460   SQUARE CENTIMETER                 LITERAL                                        SQ CM
FDA   C54458   Structured Product Labeling Potency Terminology   C48462   SQUARE YARD                       LITERAL                                        SQ YD
FDA   C54458   Structured Product Labeling Potency Terminology   C53503   STICK                             LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48538   STRIP                             LITERAL                                        STRIP
FDA   C54458   Structured Product Labeling Potency Terminology   C62420   SUPERSACK                         LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48539   SUPPOSITORY                       LITERAL                                        SUPP
FDA   C54458   Structured Product Labeling Potency Terminology   C53504   SWAB                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48540   SYRINGE                           LITERAL                                        SYR
FDA   C54458   Structured Product Labeling Potency Terminology   C48541   TABLESPOON                        LITERAL                                        TBSP
FDA   C54458   Structured Product Labeling Potency Terminology   C48542   TABLET                            LITERAL                                        TAB
FDA   C54458   Structured Product Labeling Potency Terminology   C62421   TABMINDER                         LITERAL                                        TABMIND
FDA   C54458   Structured Product Labeling Potency Terminology   C48543   TAMPON                            LITERAL                                        TAMP
FDA   C54458   Structured Product Labeling Potency Terminology   C62422   TANK                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48544   TEASPOON                          LITERAL                                        TSP
FDA   C54458   Structured Product Labeling Potency Terminology   C48545   TEST                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48546   TON                               LITERAL                                        TON
FDA   C54458   Structured Product Labeling Potency Terminology   C48547   TRACE                             LITERAL                                        TRACE
FDA   C54458   Structured Product Labeling Potency Terminology   C54704   TRAY                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48548   TROCHE                            LITERAL                                        TRO
FDA   C54458   Structured Product Labeling Potency Terminology   C48549   TUBE                              LITERAL                                        TUBE
FDA   C54458   Structured Product Labeling Potency Terminology   C48591   UNASSIGNED                        LITERAL                                        U/A
FDA   C54458   Structured Product Labeling Potency Terminology   C48469   UNITED STATES PHARMACOPEIA UNIT   LITERAL                                        USP UNIT
FDA   C54458   Structured Product Labeling Potency Terminology   C48931   UNITS                             LITERAL                                        UNITS
FDA   C54458   Structured Product Labeling Potency Terminology   C48551   VIAL                              LITERAL
FDA   C54458   Structured Product Labeling Potency Terminology   C48552   WAFER                             LITERAL                                        WAFER
FDA   C54458   Structured Product Labeling Potency Terminology   C48553   YARD                              LITERAL                                        YD
FDA   C54454   Structured Product Labeling Shape Terminology     C48335   BULLET                            The shape of a cylinder when viewing the
                                                                                                            capsule from a point perpendicular to its
                                                                                                            longest side, with a point at one end. The
                                                                                                            bullet shape is synonymous with torpedo
                                                                                                            shape.
FDA   C54454   Structured Product Labeling Shape Terminology   C48336   CAPSULE                                     The shape of a capsule when viewing the
                                                                                                                    capsule from a point perpendicular to its
                                                                                                                    longest side. The capsule shape is reserved
                                                                                                                    for two-part capsules and banded two-part
                                                                                                                    capsules. Tablets with a capsule shape or a
                                                                                                                    one part capsules (e.g., soft gelatin capsules
                                                                                                                    that are filled with a liquid) should be
                                                                                                                    classified under OVAL.

FDA   C54454   Structured Product Labeling Shape Terminology   C48337   CLOVER                                      The stylized shape, of clover, having three or
                                                                                                                    four leaves with or without the stem.
FDA   C54454   Structured Product Labeling Shape Terminology   C48338   DIAMOND                                     The shape has four distinct sides making a
                                                                                                                    parallelogram with two inner obtuse angles
                                                                                                                    and two inner acute angles. A square with
                                                                                                                    diagonal imprinting is not a diamond, but
                                                                                                                    rather, a square. See also SQUARE.

FDA   C54454   Structured Product Labeling Shape Terminology   C48339   DOUBLE CIRCLE                               The shape of two circles joined together, and
                                                                                                                    usually overlapping.
FDA   C54454   Structured Product Labeling Shape Terminology   C48340   FREEFORM                                    The shape does not have 3 or more distinct
                                                                                                                    sides and is not one of the listed shapes.
                                                                                                                    Examples include, but are not limited to,
                                                                                                                    airplane, apple, cartoon characters, heart,
                                                                                                                    kidney, shield, and train shapes.

FDA   C54454   Structured Product Labeling Shape Terminology   C48341   GEAR                                        The two dimensional shape of a toothed
                                                                                                                    wheel of a machine part.
FDA   C54454   Structured Product Labeling Shape Terminology   C48342   HEPTAGON (7 sided)                          The shape has seven distinct sides. The
                                                                                                                    sides may be straight or slightly curved. It
                                                                                                                    can either be regular (interior angles are
                                                                                                                    equal and its sides are equal in length) or
                                                                                                                    irregular (interior angles are not equal and/or
                                                                                                                    its sides are not equal in length).
FDA   C54454   Structured Product Labeling Shape Terminology   C48343   HEXAGON (6 sided)                           The shape has six distinct sides. The sides
                                                                                                                    may be straight or slightly curved. It can
                                                                                                                    either be regular (interior angles are equal
                                                                                                                    and its sides are equal in length) or irregular
                                                                                                                    (interior angles are not equal and/or its sides
                                                                                                                    are not equal in length).
FDA   C54454   Structured Product Labeling Shape Terminology   C48344   OCTAGON (8 sided)                           The shape has eight distinct sides. The
                                                                                                                    sides may be straight or slightly curved. It
                                                                                                                    can either be regular (interior angles are
                                                                                                                    equal and its sides are equal in length) or
                                                                                                                    irregular (interior angles are not equal and/or
                                                                                                                    its sides are not equal in length).
FDA   C54454   Structured Product Labeling Shape Terminology   C48345   OVAL                                        The shape of either an oval or an ellipse.
                                                                                                                    See also TEAR.
FDA   C54454   Structured Product Labeling Shape Terminology   C48346   PENTAGON (5 sided)                          The shape has five distinct sides. The sides
                                                                                                                    may be straight or slightly curved. It can
                                                                                                                    either be regular (interior angles are equal
                                                                                                                    and its sides are equal in length) or irregular
                                                                                                                    (interior angles are not equal and/or its sides
                                                                                                                    are not equal in length).
FDA   C54454   Structured Product Labeling Shape Terminology   C48347   RECTANGLE                                   The shape has four distinct sides and four
                                                                                                                    right angles but is not a square.
FDA   C54454   Structured Product Labeling Shape Terminology   C48348   ROUND                                       The shape of a circle. Spherical shapes are
                                                                                                                    called round because their two dimensional
                                                                                                                    projections are round.
FDA   C54454   Structured Product Labeling Shape Terminology   C48349   SEMI-CIRCLE                                 The shape of half of a circle or half of an
                                                                                                                    oval. This shape is also used for shapes
                                                                                                                    similar to the letter D or the letter U. Any
                                                                                                                    letter D or U that is either embossed or
                                                                                                                    debossed onto the surface of a dosage form
                                                                                                                    is not used in determining the shape of that
                                                                                                                    dosage form.
FDA   C54454   Structured Product Labeling Shape Terminology   C48350   SQUARE                                      The shape has four distinct and equal sides
                                                                                                                    with four right angles. The sides may be
                                                                                                                    straight or slightly curved. A square tilted at
                                                                                                                    a 45 degree angle so that the diagonals run
                                                                                                                    vertical and horizontal is not a diamond, but
                                                                                                                    rather, a square. See also DIAMOND.

FDA   C54454   Structured Product Labeling Shape Terminology   C48351   TEAR                                        The stylized shape of a tear or drop of water.
                                                                                                                    It differs from an oval because one end is
                                                                                                                    clearly larger than the other. It is
                                                                                                                    synonymous with the shapes egg, pear, and
                                                                                                                    almond. See also oval.
FDA   C54454   Structured Product Labeling Shape Terminology   C48352   TRAPEZOID                                   The shape has four distinct sides. The sides
                                                                                                                    may be straight or slightly curved. Only two
                                                                                                                    of the sides are parallel.
FDA   C54454   Structured Product Labeling Shape Terminology   C48353   TRIANGLE                                    The shape has three distinct sides. The
                                                                                                                    sides may be straight or slightly curved. It
                                                                                                                    can either be regular (interior angles are
                                                                                                                    equal and its sides are equal in length) or
                                                                                                                    irregular (interior angles are not equal and/or
                                                                                                                    its sides are not equal in length).
FDA   C54452   Structured Product Labeling Terminology         C16352   African American
FDA   C54452   Structured Product Labeling Terminology         C41259   American Indian or Alaska Native
FDA   C54452   Structured Product Labeling Terminology         C41260   Asian
FDA   C54452   Structured Product Labeling Terminology         C60654   Conditional Approval
FDA   C54452   Structured Product Labeling Terminology         C50646   Contraindication                            Any special symptom or circumstance that
                                                                                                                    renders the use of a remedy or the carrying
                                                                                                                    out of a procedure inadvisable, usually
                                                                                                                    because of the risk.
FDA   C54452   Structured Product Labeling Terminology         C54356   Decrease Drug Level
FDA   C54452   Structured Product Labeling Terminology         C54614   Decreased Concomitant Drug AUC
FDA   C54452   Structured Product Labeling Terminology         C54615   Decreased Concomitant Drug Cmax
FDA   C54452   Structured Product Labeling Terminology         C54616   Decreased Concomitant Drug Half Life
FDA   C54452   Structured Product Labeling Terminology         C54358   Decreased Concomitant Drug Level
FDA   C54452   Structured Product Labeling Terminology         C54617   Decreased Concomitant Drug Tmax
FDA   C54452   Structured Product Labeling Terminology         C54609   Decreased Drug AUC
FDA   C54452   Structured Product Labeling Terminology         C54606   Decreased Drug Cmax
FDA   C54452   Structured Product Labeling Terminology         C54607   Decreased Drug Half Life
FDA   C54452   Structured Product Labeling Terminology         C54608   Decreased Drug Tmax
FDA   C54452   Structured Product Labeling Terminology         C54415   Diagnostic For
FDA   C54452   Structured Product Labeling Terminology         C54346   Dose Modification
FDA   C54452   Structured Product Labeling Terminology         C60655   Duration Of Use
FDA   C54452   Structured Product Labeling Terminology         C16576   Female
FDA   C54452   Structured Product Labeling Terminology         C54357   Increase Concomitant Drug Level
FDA   C54452   Structured Product Labeling Terminology         C54613   Increased Concomitant Drug AUC
FDA   C54452   Structured Product Labeling Terminology         C54610   Increased Concomitant Drug Cmax
FDA   C54452   Structured Product Labeling Terminology         C54611   Increased Concomitant Drug Half Life
FDA   C54452   Structured Product Labeling Terminology         C54612   Increased Concomitant Drug Tmax
FDA   C54452   Structured Product Labeling Terminology         C54605   Increased Drug AUC
FDA   C54452   Structured Product Labeling Terminology         C54602   Increased Drug Cmax
FDA   C54452   Structured Product Labeling Terminology         C54603   Increased Drug Half Life
FDA   C54452   Structured Product Labeling Terminology         C54355   Increased Drug Level
FDA   C54452   Structured Product Labeling Terminology         C54604   Increased Drug Tmax
FDA   C54452   Structured Product Labeling Terminology         C54344   Limitation Of Use
FDA   C54452   Structured Product Labeling Terminology         C54352   Limited Or No Information
FDA   C54452   Structured Product Labeling Terminology         C20197   Male
FDA   C54452   Structured Product Labeling Terminology         C54027   Medical Problem                                                                               Patient Problem Code|Patient Problem
FDA   C54452   Structured Product Labeling Terminology         C54390   Medical Product Intent Of Use
FDA   C54452   Structured Product Labeling Terminology         C54416   Mitigation
FDA   C54452   Structured Product Labeling Terminology         C41219   Native Hawaiian or Other Pacific Islander
FDA   C54452   Structured Product Labeling Terminology         C54386   Pharmacokinetic Effect
FDA   C54452   Structured Product Labeling Terminology         C54354   Pharmacokinetic Effect Consequences
FDA   C54452   Structured Product Labeling Terminology         C54404   Prophylaxis For
FDA   C54452   Structured Product Labeling Terminology                                        C17049   Race
FDA   C54452   Structured Product Labeling Terminology                                        C54350   Second Line Treatment
FDA   C54452   Structured Product Labeling Terminology                                        C28421   Sex
FDA   C54452   Structured Product Labeling Terminology                                        C54398   Treat
FDA   C54452   Structured Product Labeling Terminology                                        C54351   Use With Caution
FDA   C54618   Structured Product Labeling Type of Drug Interaction Consequence Terminology   C54027   Medical Problem                                                                                Patient Problem Code|Patient Problem
FDA   C54618   Structured Product Labeling Type of Drug Interaction Consequence Terminology   C54386   Pharmacokinetic Effect
FDA   C54580   Type of Event ICSR Terminology                                                 C41331   Adverse Event
FDA   C54580   Type of Event ICSR Terminology                                                 C53054   Product Problem
FDA   C54580   Type of Event ICSR Terminology                                                 C53053   Type of Event                                                                                  Type of Reportable Event
FDA   C54592   Type Of Follow-Up ICSR Terminology                                             C53586   Additional Information
FDA   C54592   Type Of Follow-Up ICSR Terminology                                             C53585   Correction
FDA   C54592   Type Of Follow-Up ICSR Terminology                                             C53588   Device Evaluation
FDA   C54592   Type Of Follow-Up ICSR Terminology                                             C53587   Response to FDA Request
FDA   C54592   Type Of Follow-Up ICSR Terminology                                             C53584   Type of Follow-Up
FDA   C54598   Type Of Manufacturer ICSR Terminology                                          C53618   Original Equipment Manufacturer                                                                OEM
FDA   C54598   Type Of Manufacturer ICSR Terminology                                          C53614   Reprocessor
FDA   C54598   Type Of Manufacturer ICSR Terminology                                          C54597   Type Of Manufacturer
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C53604   Inspection
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C50913   Invalid Data
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C53606   Modification or Adjustment
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C53269   No Information Available                                                                       No Answer Provided
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C25297   Notification
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C17649   Other                                                                                          Other
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C53607   Patient Monitoring
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C53609   Recall                                      Recalls are regulatory actions that enable
                                                                                                                                                   FDA to remove a hazardous, potentially
                                                                                                                                                   hazardous, or a misbranded product from
                                                                                                                                                   the marketplace. Recalls are also used to
                                                                                                                                                   convey additional information to the user
                                                                                                                                                   concerning the safe use of the product.
                                                                                                                                                   Either FDA or the manufacturer can initiate
                                                                                                                                                   recalls.
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C53608   Relabeling
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C53611   Repair
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C53610   Replacement
FDA   C54594   Type Of Remedial Action ICSR Terminology                                       C53603   Type of Remedial Action
FDA   C54588   Type Of Report ICSR Terminology                                                C53580   FDA Requested
FDA   C54588   Type Of Report ICSR Terminology                                                C53576   Fifteen-Day
FDA   C54588   Type Of Report ICSR Terminology                                                C53573   Five-Day
FDA   C54588   Type Of Report ICSR Terminology                                                C53579   Follow-Up
FDA   C54588   Type Of Report ICSR Terminology                                                C53620   Initial
FDA   C54588   Type Of Report ICSR Terminology                                                C53581   Manufacturer Response to Voluntary Report
FDA   C54588   Type Of Report ICSR Terminology                                                C53578   Periodic
FDA   C54588   Type Of Report ICSR Terminology                                                C53574   Seven-Day
FDA   C54588   Type Of Report ICSR Terminology                                                C53575   Ten-Day
FDA   C54588   Type Of Report ICSR Terminology                                                C53577   Thirty-Day
FDA   C54588   Type Of Report ICSR Terminology                                                C53571   Type of Report                                                                                 Report Type
FDA   C54591   Type of Reportable Event ICSR Terminology                                      C28554   Death
FDA   C54591   Type of Reportable Event ICSR Terminology                                      C25745   Failure
FDA   C54591   Type of Reportable Event ICSR Terminology                                      C60812   Multiple Deaths And Serious Injuries
FDA   C54591   Type of Reportable Event ICSR Terminology                                      C17649   Other                                                                                          Other
FDA   C54591   Type of Reportable Event ICSR Terminology                                      C60811   Pediatric Death
FDA   C54591   Type of Reportable Event ICSR Terminology                                      C53569   Serious Injury
FDA   C54591   Type of Reportable Event ICSR Terminology                                      C53053   Type of Event                                                                                  Type of Reportable Event
FDA   C54596   Type Of Reporter ICSR Terminology                                              C53617   Importer                                    Any person who imports a device into the
                                                                                                                                                   United States and who furthers the
                                                                                                                                                   marketing of a device from the original place
                                                                                                                                                   of manufacture to the person who makes
                                                                                                                                                   final delivery or sale to the ultimate user, but
                                                                                                                                                   who does not repackage or otherwise
                                                                                                                                                   change the container, wrapper, or labeling of
                                                                                                                                                   the device or device package. If you
                                                                                                                                                   repackage or otherwise change the
                                                                                                                                                   container, wrapper, or labeling, you are
                                                                                                                                                   considered a manufacturer as defined in this
                                                                                                                                                   section.

FDA   C54596   Type Of Reporter ICSR Terminology                                              C53615   Type of Reporter                                                                               Reporter Type
FDA   C54596   Type Of Reporter ICSR Terminology                                              C53567   User Facility                               Device user facility means a hospital,
                                                                                                                                                   ambulatory surgical facility, nursing home,
                                                                                                                                                   outpatient diagnostic facility, or outpatient
                                                                                                                                                   treatment facility as defined in this section,
                                                                                                                                                   which is not a physician's office, as defined
                                                                                                                                                   in this section. School nurse offices and
                                                                                                                                                   employee health units are not device user
                                                                                                                                                   facilities.
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61629   .ALPHA.-D-GLUCOPYRANOSE, MONOHYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61650   .BETA.-D-GLUCOPYRANOSE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61651   .BETA.-D-GLUCOPYRANOSE, MONOHYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61620   2-(DIETHYLAMINO)ETHANOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61804   2-AMINO-BUTYRIC ACID,L-
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61619   2-CHLORO-4-PHENYLPHENOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C47791   2-HYDROXYETHYL METHACRYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C65128   3-TYROSINE DL-
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61817   3-TYROSINE L-
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C62014   4-((5-((CYCLOPROPYLAMINO)CARBONYL)-2-METHYLPHENYL)AMINO)-5-METHYL-N-PROPYLPYRROLO(2,1-F)(1,2,4)TRIAZINE-6-CARBOXAMIDE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61773   4-HYDROXY BUTYRIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61712   5-HYDROXY TRYPTOPHAN,DL-
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61618   7-ETHYL-10-HYDROXYCAMPTOTHECIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61523   ABACAVIR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C71608   ABACAVIR SUCCINATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C28804   ABACAVIR SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72951   ABAFUNGIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72061   ABALONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72566   ABANOQUIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C73280   ABAPERIDONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C2015    ABARELIX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C28898   ABATACEPT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72185   ABIES OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72932   ABITESARTAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C74132   ABLUKAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C74318   ABSINTHIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C73009   ABUNIDAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C71810   ACACIA DECURRENS EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72216   ACALYPHA INDICA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C65209   ACAMPROSATE CALCIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C74169   ACAPRAZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C983     ACARBOSE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72093   ACEBURIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61525   ACEBUTOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C28806   ACEBUTOLOL HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72587   ACEDIASULFONE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C74109   ACEDOBEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C74216   ACEFYLLINE CLOFIBROL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C74218   ACEFYLLINE PIPERAZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C984     ACEGLATONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C73068   ACEMETACIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72567   ACEPERONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72678   ACEPROMETAZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C74114   ACEQUINOLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72217   ACER NEGUNDO
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72218   ACER RUBRUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C198     ACETAMINOPHEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C72101   ACETAMINOSALOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61621   ACETARSONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C28809   ACETAZOLAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology       C61622   ACETAZOLAMIDE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74387   ACETERGAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61623   ACETIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72981   ACETIROMATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47380   ACETOHEXAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47381   ACETOHYDROXAMIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C29807   ACETONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65210   ACETOPHENAZINE MALEATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65211   ACETRIZOATE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72969   ACETRYPTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61624   ACETYLCARNITINE HYDROCHLORIDE, L-
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47382   ACETYLCHOLINE CHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C200     ACETYLCYSTEINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65212   ACETYLDIGITOXIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72679   ACETYLLEUCINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72982   ACIPIMOX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74133   ACITAZANOLAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73230   ACITEMATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C985     ACITRETIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C986     ACIVICIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73069   ACLANTATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71627   ACODAZOLE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65213   ACOLBIFENE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72219   ACONITUM FEROX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72220   ACONITUM LYCOCTONUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72485   ACORUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72221   ACORUS CALAMUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65214   ACOTIAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72222   ACOTIAMIDE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74418   ACOXATRINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74131   ACREOZAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65215   ACRISORCIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47383   ACRIVASTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72223   ACTAEA SPICATA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73298   ACTARIT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C205     ACYCLOVIR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47956   ACYCLOVIR SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72680   ADAFENOXATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65216   ADALIMUMAB
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74263   ADAMEXINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28989   ADAPALENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61526   ADEFOVIR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28811   ADEFOVIR DIPIVOXIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74098   ADELMIDROL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C207     ADENOSINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72224   ADIANTUM CAPILLUS VENERIS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74350   ADIBENDAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72659   ADICILLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73013   ADIMOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74259   ADITEREN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72651   ADITOPRIM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72225   ADONIS VERNALIS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74101   ADOSOPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73308   ADROGOLIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72681   ADROGOLIDE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72226   AESCULUS CARNEA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72474   AESCULUS GLABRA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72227   AETHUSA CYNAPIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72682   AFALANINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74542   AFILARIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72683   AFIMOXIFENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72970   AFUROLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74209   AGALSIDASE ALFA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74210   AGALSIDASE BETA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74229   AGANODINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72228   AGAVE AMERICANA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72229   AGAVE TEQUILANA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72684   AGOMELATINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72230   AGRIMONIA EUPATORIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72231   AGROSTIS GIGANTEA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72232   AILANTHUS GLANDULOSUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72486   AKEBIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74137   ALAFOSFALIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C29605   ALANINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61731   ALANINE, DL-
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C994     ALANOSINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72685   ALAPROCLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65217   ALATROFLOXACIN MESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72952   ALBACONAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47384   ALBENDAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72157   ALBENDAZOLE OXIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65218   ALBUMIN HUMAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C215     ALBUTEROL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47957   ALBUTEROL SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72686   ALCAFTADINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72487   ALCHEMILLA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71814   ALCHEMILLA VULGARIS EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65219   ALCLOMETASONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47385   ALCLOMETASONE DIPROPIONATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C2190    ALCOHOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C219     ALDOSTERONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65220   ALEFACEPT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72687   ALEGLITAZAR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C973     ALENDRONATE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61625   ALENDRONIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74450   ALEPRIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72233   ALETRIS FARINOSA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72167   ALFADOLONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72038   ALFALFA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71984   ALFALFA SPROUT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74371   ALFAPROSTOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72161   ALFAXALONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61626   ALFENTANIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C220     ALFENTANIL HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61627   ALFUZOSIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C53408   ALFUZOSIN HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74208   ALGLUCERASE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65221   ALGLUCOSIDASE ALFA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74231   ALIBENDOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72953   ALICONAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74249   ALILUSEM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74113   ALIMADOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73042   ALINASTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72571   ALINIDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65222   ALISKIREN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65223   ALISKIREN HEMIFUMARATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74194   ALITAME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1574    ALITRETINOIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73947   ALKANET
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74277   ALLANTOIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73184   ALLOCLAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C224     ALLOPURINOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C2564    ALLOPURINOL SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73857   ALLSPICE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C68556   ALLYL ISOTHIOCYANATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72102   ALLYLPRODINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74404   ALMESTRONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73070   ALMINOPROFEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74241   ALMITRINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74458   ALMOND
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65224   ALMOTRIPTAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61628   ALMOTRIPTAN MALATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72688   ALMOXATONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72689   ALNESPIRONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72234   ALNUS GLUTINOSA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72235   ALNUS RHOMBIFOLIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72236   ALNUS SERRULATA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65225   ALOE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71875   ALOE EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71796   ALOE FLOWER EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72198   ALOE VERA OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74324   ALORACETAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73100   ALOSETRON
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47386   ALOSETRON HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65226   ALOVUDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72690   ALOZAFONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73300   ALPERTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72134   ALPHACETYLMETHADOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72135   ALPHAMETHADOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61630   ALPHAPRODINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C2832    ALPHA-TOCOPHEROL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74578   ALPHA-TOCOPHEROL, DL-
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72237   ALPINIA OFFICINARUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73034   ALPIROPRIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72572   ALPRAFENONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C227     ALPRAZOLAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28816   ALPROSTADIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72917   ALRESTATIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72691   ALRESTATIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74423   ALTAPIZONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65227   ALTHEA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C544     ALTRETAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47387   ALUMINUM ACETATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C39707   ALUMINUM HYDROXIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65228   ALUMINUM POTASSIUM SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61631   ALUMINUM STEARATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72692   ALVERINE CITRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C49096   ALVIMOPAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74124   AMAFOLONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74253   AMANOZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61632   AMANTADINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28818   AMANTADINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73151   AMANTANIUM BROMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72693   AMANTOCILLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73320   AMBAMUSTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72573   AMBASILIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72627   AMBAZONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47388   AMBENONIUM CHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73220   AMBENOXAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72694   AMBRISENTAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74262   AMBROXOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72165   AMBUCAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47389   AMCINONIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65229   AMDINOCILLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74406   AMEBUCORT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74402   AMELOMETASONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73299   AMELUBANT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1342    AMETANTRONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28798   AMETANTRONE ACETATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72103   AMEZEPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72918   AMEZINIUM METILSULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73071   AMFENAC
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72178   AMFEPENTOREX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74237   AMFETAMINIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73272   AMICARBALIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72152   AMIDANTEL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73196   AMIDAPSONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74106   AMIDEPHRINE MESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72695   AMIFLAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73165   AMIFLOVERINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72696   AMIFLOXACIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72697   AMIFLOXACIN MESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C66724   AMIFOSTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74181   AMIGLUMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61615   AMIKACIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C230     AMIKACIN SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73160   AMIKHELLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61633   AMILORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47390   AMILORIDE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74392   AMINDOCATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74142   AMINEPTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1736    AMINOBENZOATE POTASSIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61634   AMINOBENZOIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47391   AMINOCAPROIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74414   AMINOETHYL NITRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C233     AMINOGLUTETHIMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47392   AMINOHIPPURATE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1849    AMINOLEVULINIC ACID HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72104   AMINOPHENAZONE CYCLAMATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47393   AMINOPHYLLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74554   AMINOPTERIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73273   AMINOQUINOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73152   AMINOQUINURIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72180   AMINOREX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47958   AMINOSALICYLATE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47394   AMINOSALICYLIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74177   AMINOTHIAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62002   AMIODARONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C236     AMIODARONE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74172   AMIPERONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74238   AMIPHENAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74345   AMIPIZONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74215   AMITEROL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73194   AMITIVIR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74339   AMITRAZ
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62005   AMITRIPTYLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28819   AMITRIPTYLINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72698   AMITRIPTYLINOXIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73072   AMIXETRINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47395   AMLEXANOX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61635   AMLODIPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28820   AMLODIPINE BESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65230   AMLODIPINE MALEATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72238   AMMI VISNAGA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47396   AMMONIUM CHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28821   AMMONIUM LACTATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72145   AMOCARZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65231   AMODIAQUINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65232   AMODIAQUINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72488   AMOMUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71628   AMONAFIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72652   AMOPROXAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73000   AMOPYROQUINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72916   AMOSULALOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72699   AMOTOSALEN HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47397   AMOXAPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72160   AMOXECAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C237     AMOXICILLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72700   AMOXICILLIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72239   AMPELOPSIS QUINQUEFOLIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74191   AMPEROZIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62006   AMPHETAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61636   AMPHETAMINE ASPARTATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28822   AMPHETAMINE SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73155   AMPHOTALIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C238     AMPHOTERICIN B
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C239     AMPICILLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47959   AMPICILLIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47960   AMPICILLIN TRIHYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73073   AMPIROXICAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28824   AMPRENAVIR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C240     AMSACRINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72142   AMTOLMETIN GUACIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72170   AMYLOCAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72240   AMYRIS BALSAMIFERA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72241   ANAGALLIS ARVENSIS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28825   ANAGRELIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28826   ANAGRELIDE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C38717   ANAKINRA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72701   ANAMORELIN HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1607    ANASTROZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C950     ANAXIRONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74247   ANAZOLENE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73014   ANCAROLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71906   ANCHOVY
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65233   ANCRIVIROC
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74213   ANDOLAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61637   ANDROGRAPHOLIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74316   ANDROMEDA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72242   ANEMOPSIS CALIFORNICA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74289   ANGOSTURA BARK
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72243   ANGUS CASTUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74579   ANHYDROUS LACTOSE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C38716   ANIDULAFUNGIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65234   ANILERIDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65235   ANILERIDINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72105   ANILOPAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73798   ANILOPAM HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65236   ANIRACETAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73858   ANISE SEED
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47398   ANISINDIONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74174   ANISOPIROL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65237   ANISOTROPINE METHYLBROMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74498   ANISUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73859   ANNATTO
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72106   ANPIRTOLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72702   ANSOXETINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73250   ANTAFENITE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61638   ANTAZOLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47399   ANTAZOLINE PHOSPHATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72967   ANTAZONITE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72244   ANTHOXANTHUM ODORATUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28827   ANTHRALIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74151   ANTIENITE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72107   ANTRAFENINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74246   APADENOSON
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72136   APADOLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1087    APAZIQUONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73074   APAZONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61308   APIXABAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74305   APOCYNUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72245   APOCYNUM ANDROSAEMIFOLIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72246   APOCYNUM CANNABINUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71871   APOCYNUM FLUIDEXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61639   APOMORPHINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47400   APOMORPHINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74413   APOVINCAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71985   APPLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61640   APRACLONIDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47401   APRACLONIDINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72703   APREMILAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C49173   APREPITANT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71986   APRICOT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73106   APROFENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47402   APROTININ
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72172   APTOCAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72247   AQUILEGIA VULGARIS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74303   ARALIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71868   ARALIA FLUID EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72197   ARALIA OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73022   ARANIDIPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73075   ARAPROFEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65238   ARBUTAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65239   ARBUTAMINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74248   ARCLOFENIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72489   ARECA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72704   ARECOLINE HYDROBROMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74192   ARFENDAZAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61641   ARFORMOTEROL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65240   ARFORMOTEROL TARTRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28833   ARGATROBAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72248   ARGEMONE MEXICANA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62008   ARGININE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C29606   ARGININE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47403   ARIPIPRAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72249   ARISTOLOCHIA CLEMATITIS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72250   ARISTOLOCHIA SERPENTARIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65241   ARMODAFINIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72490   ARNICA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71849   ARNICA EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73015   ARNOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74223   AROFYLLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72983   ARONIXIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72609   AROTINOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72108   ARPROMIDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1005    ARSENIC TRIOXIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73001   ARTEMETHER
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72196   ARTEMISIA OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72251   ARTEMISIA VULGARIS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73002   ARTEMOTIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73005   ARTESUNATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72173   ARTICAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47404   ARTICAINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1805    ARZOXIFENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72252   ASARUM CANADENSE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71777   ASARUM CANADENSE EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71772   ASCLEPIAS FLUIDEXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72253   ASCLEPIAS INCARNATA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72254   ASCLEPIAS SYRIACA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71834   ASCLEPIAS SYRIACA FLUID EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72255   ASCLEPIAS TUBEROSA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C285     ASCORBIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72705   ASENAPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73172   ASERIPIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C68515   ASH
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72137   ASIMADOLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72256   ASIMINA TRILOBA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72937   ASOBAMAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72574   ASOCAINOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C286     ASPARAGINASE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71987   ASPARAGUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C29608   ASPARTIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72257   ASPERULA ODORATA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C287     ASPIRIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72706   ASPOXICILLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72258   ASTACUS FLUVIATILIS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72938   ATAQUIMAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C66872   ATAZANAVIR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28835   ATAZANAVIR SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28836   ATENOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73840   ATEVIRDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73148   ATEVIRDINE MESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72707   ATIBEPRONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72921   ATIPAMEZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73076   ATLIPROFEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74141   ATOMOXETINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47405   ATOMOXETINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61527   ATORVASTATIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28837   ATORVASTATIN CALCIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28838   ATOVAQUONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28839   ATRACURIUM BESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61606   ATRASENTAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1779    ATRASENTAN HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74334   ATRINOSITOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28840   ATROPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C2744    ATROPINE SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65242   AURANOFIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74354   AVANAFIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71853   AVENS EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73327   AVITRIPTAN FUMARATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72708   AVIZAFONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47406   AVOBENZONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71988   AVOCADO
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73281   AXAMOZIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C38718   AXITINIB
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72138   AXOMADOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73282   AZABUPERONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C288     AZACITIDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74421   AZACLORZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72709   AZACLORZINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72259   AZADIRACHTA INDICA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73229   AZAFTOZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72710   AZALOXAN FUMARATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73323   AZAMETHIPHOS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73610   AZAMETHONIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72971   AZAMETHONIUM BROMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72711   AZANATOR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74219   AZANATOR MALEATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73274   AZANIDAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74187   AZAPERONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74173   AZAQUINZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74178   AZAROLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73101   AZASETRON
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74154   AZASPIRIUM CHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61642   AZATADINE MALEATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C290     AZATHIOPRINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47961   AZATHIOPRINE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47407   AZELAIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61643   AZELASTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47408   AZELASTINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73023   AZELNIDIPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72919   AZEPEXOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74408   AZETIRELIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72712   AZIDAMFENICOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74232   AZINTAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72713   AZIPRAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72714   AZIPRAMINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28844   AZITHROMYCIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C293     AZLOCILLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65243   AZLOCILLIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28845   AZTREONAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72715   AZUMOLENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65244   AZUMOLENE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72195   BABASSU OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65245   BACAMPICILLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65246   BACAMPICILLIN HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C295     BACITRACIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28857   BACITRACIN ZINC
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28858   BACLOFEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72619   BACMECILLINAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73077   BAKEPROFEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73033   BALAZIPONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72260   BALLOTA FOETIDA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72631   BALOFLOXACIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65247   BALSALAZIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47409   BALSALAZIDE DISODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74477   BALSAM, FIR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C66361   BALSAM, PERU
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74140   BAMALUZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72939   BAMAQUIMAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73948   BAMBOO
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73275   BAMNIDAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71989   BANANA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72491   BAPTISIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71801   BAPTISIA FLUIDEXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72261   BAPTISIA TINCTORIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72597   BAQUILOPRIM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28859   BARIUM SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73935   BARLEY
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73043   BARMASTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73024   BARNIDIPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72575   BARUCAINIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73979   BASIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72716   BATABULIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73257   BATABULIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72717   BATANOPRIDE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72718   BATEBULAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73283   BATOPRAZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73191   BAXITOZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73860   BAYBERRY BARK
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73598   BAZEDOXIFENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74212   BAZEDOXIFENE ACETATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72719   BAZINAPRINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71990   BEAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71991   BEAN SPROUT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71786   BEARBERRY FLUIDEXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73225   BECIPARCIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72954   BECLICONAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72989   BECLOBRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62009   BECLOMETHASONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C299     BECLOMETHASONE DIPROPIONATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61644   BECLOMETHASONE DIPROPIONATE MONOHYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74430   BECLOTIAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71932   BEEF
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71933   BEEF, COOKED
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71934   BEEF, LESS COOKED
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72003   BEET
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73222   BEFIPERIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73021   BEFUNOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72720   BEFURALINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73107   BELARIZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71993   BELL PEPPER
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65249   BELLADONNA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65250   BELLADONNA LEAF
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72262   BELLADONNA RADIX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71782   BELLIS PERENNIS EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73305   BELOTECAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C66954   BELOTECAN HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73103   BEMETIZIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74398   BEMOTRIZINOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74346   BENAFENTRINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73231   BENAXIBINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61645   BENAZEPRIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28862   BENAZEPRIL HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72907   BENAZEPRILAT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73228   BENCIANOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72972   BENCLONIDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74226   BENCYCLANE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73828   BENCYCLANE FUMARATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73261   BENDAMUSTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61565   BENDAMUSTINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74427   BENDAZOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74128   BENDERIZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47410   BENDROFLUMETHIAZIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73188   BENEXATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72936   BENFLUOREX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72721   BENFOSFORMIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74331   BENHEPAZONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74121   BENORTERONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73232   BENOXAFOS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72176   BENOXINATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65251   BENOXINATE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74126   BENRIXATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72090   BENSULDAZIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74189   BENTAZEPAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72955   BENTEMAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65252   BENTIROMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C2591    BENZALDEHYDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74411   BENZARONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74412   BENZBROMARONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C302     BENZENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73007   BENZETIMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72943   BENZILONIUM BROMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73819   BENZINDOPYRINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74127   BENZIODARONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28923   BENZOCAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61646   BENZOIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73251   BENZOXONIUM CHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47411   BENZOYL PEROXIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73820   BENZOYLPAS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72603   BENZOYLPAS CALCIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61647   BENZPHETAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61648   BENZPHETAMINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74267   BENZQUERCIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65253   BENZQUINAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65254   BENZTHIAZIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61649   BENZTROPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28864   BENZTROPINE MESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65255   BENZYL BENZOATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72590   BEPERIDIUM IODIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73044   BEPIASTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47412   BEPRIDIL HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72263   BERBERIS AQUIFOLIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72264   BERBERIS VULGARIS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72576   BERLAFENONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73078   BERMOPROFEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73861   BERRY
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61568   BERUBICIN HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74244   BESIGOMSIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74254   BESULPAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74257   BESUNIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73794   BETAHISTINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C303     BETAMETHASONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65256   BETAMETHASONE ACETATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74405   BETAMETHASONE ACIBUTATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65257   BETAMETHASONE BENZOATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47963   BETAMETHASONE DIPROPIONATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47964   BETAMETHASONE SODIUM PHOSPHATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47962   BETAMETHASONE VALERATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72565   BETAMIPRON
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61652   BETAXOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47413   BETAXOLOL HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65258   BETAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65259   BETAZOLE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28866   BETHANECHOL CHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65260   BETHANIDINE SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65261   BETIATIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72175   BETOXYCAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73801   BETOXYCAINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C2039    BEVACIZUMAB
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73804   BEVONIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72944   BEVONIUM METILSULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1635    BEXAROTENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72109   BEZITRAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72620   BIAPENEM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73821   BIBENZONIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73180   BIBENZONIUM BROMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74156   BIBROCATHOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1599    BICALUTAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72990   BICLOFIBRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73252   BICLOTYMOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73602   BIETAMIVERINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72973   BIETASERPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72110   BIFEPRAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73079   BIFEPROFEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65262   BIFEPRUNOX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73045   BILASTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71873   BILBERRY EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47414   BIMATOPROST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72942   BIMOSIAMOSE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73803   BIMOSIAMOSE DISODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72722   BINEDALINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72632   BINFLOXACIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72991   BINIFIBRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74130   BINIZOLAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73223   BINOSPIRONE MESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74338   BIORESMETHRIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C309     BIOTIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65263   BIPERIDEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65264   BIPERIDEN HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65265   BIPERIDEN LACTATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71621   BIRICODAR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1653    BIRICODAR DICITRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28870   BISACODYL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72956   BISBENDAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1020    BISMUTH SUBSALICYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73611   BISNAFIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73307   BISNAFIDE DIMESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65266   BISOCTRIZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61653   BISOPROLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28871   BISOPROLOL FUMARATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74171   BISORCIC
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65267   BITOLTEROL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65268   BITOLTEROL MESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72149   BITOSCANATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47415   BIVALIRUDIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71983   BLACK OLIVE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72054   BLACK WALNUT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73862   BLACK WALNUT BARK
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71832   BLACK WALNUT EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73863   BLACK WALNUT LEAVES
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71601   BLACKBERRY
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71995   BLACK-EYED PEA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C313     BLEOMYCIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C312     BLEOMYCIN SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72265   BLESSED THISTLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73980   BLUE SKULLCAP
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71996   BLUEBERRY
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71817   BLUEBERRY LEAF EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74111   BOLASTERONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72928   BOLAZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74496   BOLDO
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74294   BOLDO LEAF OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72610   BOMETOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73976   BORAGE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73864   BORAGE FLOWERS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47416   BORIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1851    BORTEZOMIB
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47417   BOSENTAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C60809   BOSUTINIB
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74163   BOTIACRINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74380   BRALLOBARBITAL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72266   BRASSICA NAPUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73265   BRAZERGOLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72048   BRAZIL NUT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72653   BREFONALOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1560    BREQUINAR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1078    BREQUINAR SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72111   BRETAZENIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47418   BRETYLIUM TOSYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65269   BRIMONIDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47419   BRIMONIDINE TARTRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72623   BRINAZARONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47420   BRINZOLAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C53397   BRIVANIB ALANINATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65270   BRIVARACETAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C67088   BRIVUDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72621   BROBACTAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71997   BROCCOLI
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74168   BROCLEPRIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73255   BRODIMOPRIM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72723   BROFAROMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74329   BROFEZIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72957   BROLACONAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73259   BROMACRYLIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74384   BROMAMID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73154   BROMCHLORENONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72089   BROMEBRIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73311   BROMERGURIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74179   BROMETENAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65271   BROMFENAC
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65272   BROMFENAC SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74161   BROMOCICLEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62010   BROMOCRIPTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C317     BROMOCRIPTINE MESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61654   BROMODIPHENHYDRAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47421   BROMODIPHENHYDRAMINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73322   BROMOFENOFOS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73324   BROMOFOS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73035   BROMOPRIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72148   BROMOXANIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61655   BROMPHENIRAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47422   BROMPHENIRAMINE MALEATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47423   BROMTHYMOL BLUE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72267   BROMUS SECALINUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1024    BROPIRIMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73256   BROQUINALDOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74330   BROSOTAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73246   BROSUXIMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72595   BROTIANIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74261   BROVANEXINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74419   BROVINCAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71945   BROWN SUGAR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72598   BROXALDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74195   BROXATEROL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72095   BROXITALAMIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73253   BROXYQUINOLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71998   BRUSSELS SPROUT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74314   BRYONIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72268   BRYONIA CRETICA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72112   BUCETIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71838   BUCHU LEAVES EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73198   BUCICLOVIR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71780   BUCKTHORN EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73936   BUCKWHEAT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65273   BUCLIZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65274   BUCLIZINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72958   BUCLOSAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72087   BUCLOXIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73080   BUCOLOME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72141   BUCRICAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72577   BUCROMARONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72611   BUCUMOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1027    BUDESONIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73271   BUDIPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73046   BUFENADRINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72612   BUFETOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73081   BUFEZOLAC
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72940   BUFROLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72613   BUFURALOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72113   BUMADIZONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72171   BUMECAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73108   BUMEPIDIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28875   BUMETANIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74400   BUMETRIZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72578   BUNAFTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74136   BUNAPROLAST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72922   BUNAZOSIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72614   BUNITROLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73276   BUPARVAQUONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62011   BUPIVACAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28876   BUPIVACAINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72615   BUPRANOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61656   BUPRENORPHINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47424   BUPRENORPHINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62012   BUPROPION
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1317    BUPROPION HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74355   BUQUINERAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73159   BUQUITERINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74313   BURDOCK
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71820   BURDOCK FLUIDEXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73865   BURDOCK ROOT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71790   BURNET EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74424   BURODILINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62013   BUSPIRONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C26641   BUSPIRONE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C321     BUSULFAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61657   BUTABARBITAL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65275   BUTABARBITAL SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73233   BUTAFOSFAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47425   BUTALBITAL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74104   BUTAMOXANE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65276   BUTANE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73082   BUTANIXIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73061   BUTANSERIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74164   BUTANTRONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74369   BUTAPROST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73169   BUTAVERINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72092   BUTEDRONIC ACID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72959   BUTENAFINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47426   BUTENAFINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74422   BUTERIZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73176   BUTETAMATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73083   BUTIBUFEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47427   BUTOCONAZOLE NITRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61659   BUTORPHANOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61658   BUTORPHANOL TARTRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71930   BUTTER
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72059   BUTTERMILK
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C44347   BUTYLATED HYDROXYANISOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C322     BUTYLATED HYDROXYTOLUENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65277   BUTYLSCOPOLAMINE BROMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72269   BUXUS SEMPERVIRENS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71999   CABBAGE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47428   CABERGOLINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72270   CACTUS GRANDIFLORUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C328     CAFFEINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1033    CAFFEINE CITRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74291   CAJEPUT OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74288   CALAMUS OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65278   CALCIFEDIOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28900   CALCIPOTRIENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C329     CALCITONIN, SALMON
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C330     CALCITRIOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47429   CALCIUM ACETATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C332     CALCIUM CARBONATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61660   CALCIUM CATION
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28901   CALCIUM CHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1355    CALCIUM CITRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65279   CALCIUM GLUCEPTATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C336     CALCIUM GLUCONATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74545   CALCIUM PANTOTHENATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65280   CALCIUM SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65281   CALCIUM SULFATE DIHYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65282   CALCIUM SULFATE, ANHYDROUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72492   CALENDULA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71837   CALENDULA EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73866   CALENDULA FLOWER
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72194   CALENDULA OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72271   CALOTROPIS GIGANTEA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72272   CALTHA PALUSTRIS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C337     CALUSTERONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65283   CAMELLIA OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72724   CAMOBUCOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73213   CAMOSTAT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28136   CAMPHOR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72193   CAMPHOR OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72493   CANANGA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65284   CANDESARTAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28903   CANDESARTAN CILEXETIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1880    CANERTINIB DIHYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72273   CANNABIS SATIVA L
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72057   CANTALOUPE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C68309   CANTHAXANTHIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74463   CAPE ALOES
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1794    CAPECITABINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72607   CAPREOMYCIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73797   CAPREOMYCIN SULFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C339     CAPSAICIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C340     CAPTOPRIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74301   CARAWAY
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47430   CARBACHOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C341     CARBAMAZEPINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61661   CARBAMIC ACID, C-14
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C343     CARBENICILLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65285   CARBENICILLIN DISODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1409    CARBENICILLIN INDANYL SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47431   CARBIDOPA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61803   CARBIDOPA, L- ANHYDROUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65286   CARBINOXAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47432   CARBINOXAMINE MALEATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65287   CARBOCLORAL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65288   CARBON DIOXIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C44350   CARBON TETRACHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1282    CARBOPLATIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61662   CARBOPROST
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47433   CARBOPROST TROMETHAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74464   CARDAMOM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72274   CARDUUS MARIANUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28904   CARISOPRODOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73867   CARLINE THISTLE ROOT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C349     CARMUSTINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73173   CAROVERINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72725   CAROXAZONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73284   CARPERONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73285   CARPHENAZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65289   CARPHENAZINE MALEATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72275   CARPINUS BETULUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65290   CARPROFEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72000   CARROT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65291   CARTEOLOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28905   CARTEOLOL HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72276   CARTHAMUS TINCTORIOUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28906   CARVEDILOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65292   CARVEDILOL PHOSPHATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72277   CARYA TOMENTOSA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73868   CASCARILLA BARK
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74286   CASCARILLA OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72049   CASHEW
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71635   CASOPITANT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61086   CASOPITANT MESYLATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28910   CASPOFUNGIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1724    CASPOFUNGIN ACETATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72278   CASSIA ANGUSTIFOLIA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65293   CASSIA OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72279   CASTANEA VESCA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71919   CATFISH
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73978   CATNIP
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72055   CAULIFLOWER
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72494   CAULOPHYLLUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72058   CAVIAR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72280   CEANOTHUS AMERICANUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28911   CEFACLOR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28912   CEFADROXIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47965   CEFADROXIL HEMIHYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C353     CEFAMANDOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47966   CEFAMANDOLE NAFATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47967   CEFAMANDOLE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28913   CEFAZOLIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47968   CEFAZOLIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28914   CEFDINIR
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72625   CEFDITOREN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47434   CEFDITOREN PIVOXIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65294   CEFEPIME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1041    CEFEPIME HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1100    CEFIXIME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65295   CEFMENOXIME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65296   CEFMENOXIME HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65297   CEFMETAZOLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65298   CEFMETAZOLE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65299   CEFONICID
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65300   CEFONICID SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61663   CEFOPERAZONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47435   CEFOPERAZONE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47436   CEFORANIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C354     CEFOTAXIME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C2328    CEFOTAXIME SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61664   CEFOTETAN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47437   CEFOTETAN DISODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65301   CEFOTIAM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65302   CEFOTIAM HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61665   CEFOXITIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28915   CEFOXITIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65303   CEFPIRAMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65304   CEFPIRAMIDE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65305   CEFPODOXIME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28916   CEFPODOXIME PROXETIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28917   CEFPROZIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C66868   CEFTAZIDIME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C355     CEFTAZIDIME SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61666   CEFTIBUTEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61667   CEFTIBUTEN DIHYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61668   CEFTIZOXIME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47438   CEFTIZOXIME SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65306   CEFTOBIPROLE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62020   CEFTRIAXONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C817     CEFTRIAXONE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61669   CEFUROXIME
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28918   CEFUROXIME AXETIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47439   CEFUROXIME SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1728    CELECOXIB
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72001   CELERIAC
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71931   CELERIAC, COOKED
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71975   CELERIAC, RAW
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71994   CELERY
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71848   CELERY EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73524   CELERY OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73869   CELERY SEED
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72281   CENTAURIUM ERYTHRAEA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71816   CENTAURIUM ERYTHRAEA EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C356     CEPHALEXIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47969   CEPHALEXIN HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65307   CEPHALOGLYCIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C62021   CEPHALOTHIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C358     CEPHALOTHIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61670   CEPHAPIRIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47440   CEPHAPIRIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47441   CEPHRADINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47970   CEPHRADINE DIHYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47971   CEPHRADINE MONOHYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65308   CERIVASTATIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28919   CERIVASTATIN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65309   CERULETIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65310   CERULETIDE DIETHYLAMINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73814   CETABEN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72984   CETABEN SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1042    CETIRIZINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28920   CETIRIZINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73149   CETRIMONIUM BROMIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C2481    CETRORELIX
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1723    CETUXIMAB
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47442   CETYL ALCOHOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C66873   CEVIMELINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C1337    CEVIMELINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73815   CEVIPABULIN FUMARATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73870   CHAMOMILE TEA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73523   CHAULMOOGRA OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72495   CHEIRANTHUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72282   CHELIDONIUM MAJUS
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65206   CHENODIOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72184   CHENOPODIUM OIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65311   CHERRY
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71992   CHICKPEA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74097   CHIMAPHILA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72283   CHIMAPHILA UMBELLATA
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C74502   CHINA ROOT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71781   CHINESE CHRYSANTHEMUM EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71799   CHINESE QUINCE EXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C71860   CHIONANTHUS FLUIDEXTRACT
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73974   CHIVE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C73183   CHLOPHEDIANOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65312   CHLOPHEDIANOL HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28922   CHLORAL HYDRATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C362     CHLORAMBUCIL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C363     CHLORAMPHENICOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65313   CHLORAMPHENICOL PALMITATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47972   CHLORAMPHENICOL SODIUM SUCCINATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C29814   CHLORDANE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47443   CHLORDIAZEPOXIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47973   CHLORDIAZEPOXIDE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C364     CHLORHEXIDINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47974   CHLORHEXIDINE GLUCONATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65314   CHLORHEXIDINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C365     CHLORMADINONE ACETATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65315   CHLORMERODRIN
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65316   CHLORMEZANONE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65317   CHLOROBUTANOL
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C29815   CHLOROFORM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C72168   CHLOROPROCAINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47444   CHLOROPROCAINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C61671   CHLOROQUINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65318   CHLOROQUINE HYDROCHLORIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47445   CHLOROQUINE PHOSPHATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C28924   CHLOROTHIAZIDE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65319   CHLOROTHIAZIDE SODIUM
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65320   CHLOROTRIANISENE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C47446   CHLOROXINE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminology   C65322   CHLORPHENESIN CARBAMATE
FDA   C63923   FDA Established Names and Unique Ingredient Identifier Codes Terminol