PROPECIA
These highlights do not include all the information needed to use PROPECIA safely and effectively. See full prescribing information for PROPECIA. PROPECIA (finasteride) tablets for oral use Initial U.S. Approval: 1992
Approved
Approval ID
9e7329eb-39f1-4f84-a0bb-91daffaba1c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 11, 2013
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
NDC Product Code54868-4120
Application NumberNDA020788
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJune 11, 2013
Generic Namefinasteride
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FINASTERIDEActive
Quantity: 1 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT