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
df82de18-6113-4644-a54d-b57b646956c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2022
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 Code71713-096
Application NumberANDA091643
Product Classification
M
Marketing Category
C73584
G
Generic Name
Finasteride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2022
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LAUROYL PEG-32 GLYCERIDESInactive
Code: H5ZC52369M
Classification: IACT
FINASTERIDEActive
Quantity: 1 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT