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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1047
Application NumberANDA208960
Product Classification
M
Marketing Category
C73584
G
Generic Name
VARDENAFIL
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1049
Application NumberANDA208960
Product Classification
M
Marketing Category
C73584
G
Generic Name
VARDENAFIL
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1048
Application NumberANDA208960
Product Classification
M
Marketing Category
C73584
G
Generic Name
VARDENAFIL
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1050
Application NumberANDA208960
Product Classification
M
Marketing Category
C73584
G
Generic Name
VARDENAFIL
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
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