Levetiracetam (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 473 mL Label

MGP

NDC 60432-831-16

LEVETIRACETAM

ORAL SOLUTION,

100 mg/mL

ATTENTION PHARMACIST: Each

patient is required to receive the

accompanying Medication Guide.

DO NOT USE IF TAMPER-EVIDENT SEAL

IS BROKEN OR MISSING.

Rx Only

NET: 16 fl oz (473 mL)

Levetiracetam Oral Solution Label
(click image for full-size original)

Levetiracetam Oral Solution Label

LEVETIRACETAM levetiracetam solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-831
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
AMMONIUM GLYCYRRHIZATE
GLYCERIN
MALTITOL
METHYLPARABEN
ACESULFAME POTASSIUM
PROPYLPARABEN
WATER
TRISODIUM CITRATE DIHYDRATE
ANHYDROUS CITRIC ACID
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-831-16 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090028 03/18/2010
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)
Establishment
Name Address ID/FEI Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS (60432-831), LABEL (60432-831), PACK (60432-831), MANUFACTURE (60432-831)

Revised: 10/2020 Morton Grove Pharmaceuticals, Inc.

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