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
e593ab58-70a4-4095-8091-16a4b6d49e4d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-7655
Application NumberANDA091347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VARDENAFIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Vardenafil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7653
Application NumberANDA091347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (12)
VARDENAFIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Vardenafil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7654
Application NumberANDA091347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (12)
VARDENAFIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Vardenafil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7652
Application NumberANDA091347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (12)
VARDENAFIL HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT