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  7. Drug Nomenclature Monographs
  1. Data Standards Manual (monographs)

Drug Nomenclature Monographs

Drug Nomenclature Monographs

Monograph Number

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

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