VARDENAFIL
VARDENAFIL HYDROCHLORIDE TABLETS
Approved
Approval ID
8ea14f7e-44a0-4d9c-968a-87b97ca12f09
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VARDENAFIL
PRODUCT DETAILS
NDC Product Code70771-1047
Application NumberANDA208960
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2022
Generic NameVARDENAFIL
INGREDIENTS (8)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
VARDENAFIL HYDROCHLORIDE TRIHYDRATEActive
Quantity: 2.5 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
VARDENAFIL
PRODUCT DETAILS
NDC Product Code70771-1049
Application NumberANDA208960
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2022
Generic NameVARDENAFIL
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
VARDENAFIL HYDROCHLORIDE TRIHYDRATEActive
Quantity: 10 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VARDENAFIL
PRODUCT DETAILS
NDC Product Code70771-1048
Application NumberANDA208960
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2022
Generic NameVARDENAFIL
INGREDIENTS (10)
VARDENAFIL HYDROCHLORIDE TRIHYDRATEActive
Quantity: 5 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
VARDENAFIL
PRODUCT DETAILS
NDC Product Code70771-1050
Application NumberANDA208960
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2022
Generic NameVARDENAFIL
INGREDIENTS (10)
VARDENAFIL HYDROCHLORIDE TRIHYDRATEActive
Quantity: 20 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/1/2018
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1047-3
Vardenafil Tablets, 2.5 mg
30 Tablets
Rx only
NDC 70771-1048-3
Vardenafil Tablets, 5 mg
30 Tablets
Rx only
NDC 70771-1049-3
Vardenafil Tablets, 10 mg
30 Tablets
Rx only
NDC 70771-1050-3
Vardenafil Tablets, 20 mg
30 Tablets
Rx only
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 9/22/2020