Tadalafil
These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
059b4496-bbfd-4058-ab03-91c5c223b945
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tadalafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71610-325
Application NumberANDA208934
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2019
FDA Product Classification
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
TADALAFILActive
Quantity: 20 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Tadalafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71610-324
Application NumberANDA208934
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2019
FDA Product Classification
INGREDIENTS (13)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TADALAFILActive
Quantity: 5 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT