Finasteride
These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE TABLETS for oral use Initial U.S. Approval: 1992
Approved
Approval ID
3fe7bdaa-b027-4da9-94ee-550bf28c63e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2021
Manufacturers
FDA
Thirty Madison Inc
DUNS: 080774087
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Finasteride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71713-099
Application NumberANDA207750
Product Classification
M
Marketing Category
C73584
G
Generic Name
Finasteride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2020
FDA Product Classification
INGREDIENTS (12)
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
FINASTERIDEActive
Quantity: 1 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LAUROYL PEG-32 GLYCERIDESInactive
Code: H5ZC52369M
Classification: IACT