Vardenafil
These highlights do not include all the information needed to use VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS. VARDENAFIL HYDROCHLORIDE orally disintegrating tablets Initial U.S. Approval: 2003
Approved
Approval ID
0ce4eb7b-fa50-441d-ae71-eb33dca27926
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 1
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 Code62332-235
Application NumberANDA208324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vardenafil
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2023
FDA Product Classification
INGREDIENTS (10)
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
VARDENAFIL HYDROCHLORIDE TRIHYDRATEActive
Quantity: 10 mg in 1 1
Code: 5M8S2CU0TS
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT