Levitra
LEVITRA (vardenafil HCl)TABLETS
Approved
Approval ID
b3bbc16e-8305-469a-9dc3-8e698339a98b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 8, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-4967
Application NumberNDA021400
Product Classification
M
Marketing Category
C73594
G
Generic Name
vardenafil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2010
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
VARDENAFIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIB
vardenafil hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4984
Application NumberNDA021400
Product Classification
M
Marketing Category
C73594
G
Generic Name
vardenafil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2010
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VARDENAFIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT