Vardenafil Hydrochloride
These highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
a38de6e1-21ca-4ebe-a3c7-6f849cf8b675
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 10, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vardenafil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-154
Application NumberANDA204632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2023
FDA Product Classification
INGREDIENTS (10)
VARDENAFILActive
Quantity: 20 mg in 1 1
Code: UCE6F4125H
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Vardenafil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-153
Application NumberANDA204632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2023
FDA Product Classification
INGREDIENTS (10)
VARDENAFILActive
Quantity: 10 mg in 1 1
Code: UCE6F4125H
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Vardenafil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-151
Application NumberANDA204632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2023
FDA Product Classification
INGREDIENTS (8)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
VARDENAFILActive
Quantity: 2.5 mg in 1 1
Code: UCE6F4125H
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Vardenafil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-152
Application NumberANDA204632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2023
FDA Product Classification
INGREDIENTS (10)
VARDENAFILActive
Quantity: 5 mg in 1 1
Code: UCE6F4125H
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT