LEVETIRACETAM (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62332-626 -16
Levetiracetam
Oral Solution, USP
100 mg/mL
Dispense accompanying Medicaton
Guide to each patient.
Rx only
16 fl oz (473 mL)Alembic

100 mg/mL
(click image for full-size original)
LEVETIRACETAM levetiracetam solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-626
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
GLYCERIN
MALTITOL
METHYLPARABEN
AMMONIUM GLYCYRRHIZATE
PROPYLPARABEN
WATER
SODIUM CITRATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-626-16 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203067 09/12/2019
Labeler — Alembic Pharmaceuticals Inc. (079288842)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 161630033 MANUFACTURE (62332-626)

Revised: 11/2019 Alembic Pharmaceuticals Inc.

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