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
e6be198c-2a5a-4442-8b6d-4ed21a740065
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 3
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 Code69238-1153
Application NumberANDA210738
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (11)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
VARDENAFIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Vardenafil hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1152
Application NumberANDA210738
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (11)
VARDENAFIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Vardenafil hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1151
Application NumberANDA210738
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (11)
VARDENAFIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT