Finasteride and Tadalafil
These highlights do not include all the information needed to use FINASTERIDE AND TADALAFIL CAPSULES safely and effectively. See full prescribing information for FINASTERIDE AND TADALAFIL CAPSULES. FINASTERIDE AND TADALAFIL capsules, for oral use Initial U.S. Approval: 2021
Approved
Approval ID
7f32151f-3c34-4818-890b-34f22f5e83ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2025
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Finasteride and Tadalafil
PRODUCT DETAILS
NDC Product Code70954-652
Application NumberANDA218499
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 24, 2025
Generic NameFinasteride and Tadalafil
INGREDIENTS (21)
TADALAFILActive
Quantity: 5 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FINASTERIDEActive
Quantity: 5 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT