Levetiracetam (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42043-193-06

Levetiracetam

Tablets

1000 mg

ATTENTION PHARMACIST: Each patient is required to receive the medication guide. Dispense one medication guide provided separately.

Rx only

60 Tablets

Karalex

Karalex Pharma, LLC

label1
(click image for full-size original)
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42043-193
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levetiracetam (Levetiracetam) Levetiracetam 1000 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POVIDONE
POLYETHYLENE GLYCOL 6000
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 4000
TITANIUM DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL (Oblong) Size 21mm
Flavor Imprint Code L;1G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42043-193-06 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090484 09/01/2011
Labeler — Karalex Pharma LLC (809429207)

Revised: 07/2011 Karalex Pharma LLC

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