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
NDC Product Code71335-1634
Application NumberANDA090121
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 2, 2016
Generic Namefinasteride
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