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
9b38c8c7-01e4-45d0-b4ee-3546d9ad849c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2023
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
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 Code67877-288
Application NumberANDA204304
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 11, 2022
Generic NameFinasteride
INGREDIENTS (10)
FINASTERIDEActive
Quantity: 5 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT