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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69681-125
Application NumberNDA215423
Product Classification
M
Marketing Category
C73594
G
Generic Name
finasteride and tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2021
FDA Product Classification
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