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 5 mg, for oral use Initial U.S. Approval: 1992
Approved
Approval ID
88511bd5-624e-49d6-b80e-1f1d47314fb6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2020
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-1634
Application NumberANDA090121
Product Classification
M
Marketing Category
C73584
G
Generic Name
finasteride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2016
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FINASTERIDEActive
Quantity: 5 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB