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

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.