LEVETIRACETAM (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

– 473 mL Bottle Label

NDC 10135-0695-08

Levetiracetam
Oral Solution, USP

100 mg/mL

Dispense accompanying
Medication Guide to each patient.

Rx only

16 fl oz (473 mL)

PRINCIPAL DISPLAY PANEL -- 473 mL Bottle Label
NDC 10135-0695-08
Levetiracetam
Oral Solution, USP
100 mg/mL
Dispense accompanying
Medication Guide
to each patient.
Rx only
16 fl oz (473 mL)
(click image for full-size original)

LEVETIRACETAM levetiracetam solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-695
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
PROPYLENE GLYCOL
CITRIC ACID MONOHYDRATE
GLYCERIN
SORBITOL SOLUTION
METHYLPARABEN
SUCRALOSE
PROPYLPARABEN
WATER
SODIUM CITRATE
Product Characteristics
Color WHITE (clear, colorless to faintly yellow) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-695-08 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078582 03/01/2020
Labeler — Marlex Pharmaceuticals Inc (782540215)

Revised: 01/2020 Marlex Pharmaceuticals Inc

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