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
a2e7f393-5cfc-45e5-b87d-9e8abc8e4355
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 25, 2023
Manufacturers
FDA
Burel Pharmaceuticals, LLC
DUNS: 609436204
Products 4
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 Code35573-461
Application NumberANDA215556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TADALAFILActive
Quantity: 5 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
Tadalafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35573-462
Application NumberANDA215556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2023
FDA Product Classification
INGREDIENTS (11)
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TADALAFILActive
Quantity: 10 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Tadalafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35573-460
Application NumberANDA215556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TADALAFILActive
Quantity: 2.5 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
Tadalafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35573-463
Application NumberANDA215556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TADALAFILActive
Quantity: 20 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB