Finasteride
Approved
Approval ID
e3469758-5111-4c30-a7fc-12444e914515
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5636
Application NumberANDA077914
Product Classification
M
Marketing Category
C73584
G
Generic Name
finasteride
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2011
FDA Product Classification
INGREDIENTS (10)
FINASTERIDEActive
Quantity: 5 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT