Finasteride
Finasteride Tablets USP, 5 mg RX Only
Approved
Approval ID
c59f8018-fff8-4884-a3c8-bc306e2c8f64
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2010
Manufacturers
FDA
Camber Pharmaceuticals Inc.
DUNS: 826774775
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 Code31722-525
Application NumberANDA090061
Product Classification
M
Marketing Category
C73584
G
Generic Name
Finasteride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2010
FDA Product Classification
INGREDIENTS (13)
FINASTERIDEActive
Quantity: 5 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT