Vardenafil (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62332-235-04
Vardenafil Hydrochloride
Orally Disintegrating Tablets, USP
10 mg* per Tablet
Place the orally
disintegrating
tablet in the
mouth, on the
tongue.
The orally
disintegrating
tablet should be
taken without
liquid.
Rx only
4 Tablets Alembic

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VARDENAFIL vardenafil tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-235
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE (VARDENAFIL) VARDENAFIL 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
SILICON DIOXIDE
ASPARTAME
CITRIC ACID MONOHYDRATE
PEPPERMINT
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 477
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-235-04 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (62332-235-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208324 11/20/2018
Labeler — Alembic Pharmaceuticals Inc. (079288842)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (62332-235)

Revised: 09/2023 Alembic Pharmaceuticals Inc.

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