ENTADFI
These highlights do not include all the information needed to use ENTADFI safely and effectively. See full prescribing information for ENTADFI. ENTADFI™ (finasteride and tadalafil) capsules, for oral useInitial U.S. Approval: 2021
Approved
Approval ID
112bf653-8322-4444-8d4d-03234b11c38c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2023
Manufacturers
FDA
Veru Inc.
DUNS: 055300578
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 Code69681-125
Application NumberNDA215423
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 12, 2021
Generic Namefinasteride and tadalafil
INGREDIENTS (12)
tadalafilActive
Quantity: 5 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
finasterideActive
Quantity: 5 mg in 1 1
Code: 57GNO57U7G
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT