U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Forms & Submission Requirements
  5. Electronic Regulatory Submission and Review
  6. Data Standards Manual (monographs)
  7. Drug Nomenclature Monographs
  1. Data Standards Manual (monographs)

Drug Nomenclature Monographs

Drug Nomenclature Monographs

Monograph Number

Drug ClassificationC-DRG-00101
Dosage FormC-DRG-00201 (FDA Archive)
Route of AdministrationC-DRG-00301
Ingredient NameC-DRG-00401
Proprietary NameC-DRG-00402 (FDA Archive)
Animal Common NamesC-DRG-00403 (FDA Archive)
Animal Cell Tissue Fluid BiomoleculeC-DRG-00404 (FDA Archive)
Biotechnology OriginC-DRG-00405 (FDA Archive)
PotencyC-DRG-00501
IndicationsC-DRG-00601 (FDA Archive)
Therapeutic Equivalence CodeC-DRG-00701 (FDA Archive)
Phase 4 Commitment CategoryC-DRG-00901
Phase 4 Fulfillment CategoryC-DRG-00902 (FDA Archive)
Pediatric use Supplement RuleC-DRG-00903 (FDA Archive)
Pediatric Use Supplement Clinical Efficacy Trials CategoryC-DRG-00904 (FDA Archive)
Pediatric Use Supplement PK/PD CategoryC-DRG-00905 (FDA Archive)
Pediatric Use Supplement Safety/Adverse Reaction CategoryC-DRG-00906 (FDA Archive)
Package TypeC-DRG-00907
Pediatric Exclusivity Study TypeC-DRG-00908 (FDA Archive)
Pediatric Exclusivity Study Age GroupC-DRG-00909
Pediatric Exclusivity Study BasisC-DRG-00910 (FDA Archive)
Pediatric Exclusivity Study Drug ListC-DRG-00911 (FDA Archive)
Geriatric Use Supplement RuleC-DRG-00913 (FDA Archive)
Geriatric Use Supplement Clinical Efficacy Trials CategoryC-DRG-00914 (FDA Archive)
Geriatric Use Supplement PK/PD CategoryC-DRG-00915 (FDA Archive)
Geriatric Use Supplement Safety/Adverse Reaction CategoryC-DRG-00916 (FDA Archive)
Industry Meeting TypeC-DRG-00917
Industry Meeting ResponseC-DRG-00918 (FDA Archive)
PACT Commitment CategoryC-DRG-00919 (FDA Archive)
PACT Fulfillment CategoryC-DRG-00920 (FDA Archive)
Global Suplement StatusC-DRG-00921 (FDA Archive)
Plant PartC-DRG-00924 (FDA Archive)
SPL CoatingC-DRG-0925 (FDA Archive)
SPL SymbolC-DRG-0926 (FDA Archive)
SPL ColorC-DRG-0927
SPL SizeC-DRG-0928 (FDA Archive)
SPL ShapeC-DRG-0929
SPL ScoreC-DRG-0930 (FDA Archive)
SPL ImprintC-DRG-0931 (FDA Archive)
SPL ImageC-DRG-0932 (FDA Archive)
SPL DEA ScheduleC-DRG-0933
SPL Flavor C-DRG-0934 (FDA Archive)
Marketing CategoryC-DRG-0935

Back to Top

 

 

Back to Top