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
01b88593-99d3-4dd6-a7b6-5438c15bd7b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 2, 2022
Manufacturers
FDA
Rising Health, LLC
DUNS: 080500961
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Finasteride
PRODUCT DETAILS
NDC Product Code57237-061
Application NumberANDA203687
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 24, 2022
Generic NameFinasteride
INGREDIENTS (11)
FINASTERIDEActive
Quantity: 1 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT