CARBAMAZEPINE (Page 6 of 6)

HOW SUPPLIED

Carbamazepine tablets USP, 200 mg are available as round, white, single-scored tablets, debossed “T” — “109”.

Supplied in bottles of 100 and 1000.

Carbamazepine chewable tablets USP, 100 mg are available as round, single-scored tablets, pink with red specks, debossed “93” — “93”/“778”.

Supplied in bottles of 100.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from moisture. Store in a dry place.

Dispense in a tight container, preferably glass, as defined in the USP.

Dispense in a container labeled: Store in a dry place. Protect from moisture.

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. AD 5/2009

CARBAMAZEPINE 200MG LABEL

CARBAMAZEPINE carbamazepine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-475(NDC:0093-0109) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 200 mg

Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE CROSCARMELLOSE SODIUM ETHYLCELLULOSE GLYCERIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE

Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code T;109 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16590-475-30 30 TABLET (TABLET) in 1 BOTTLE None 2 NDC:16590-475-60 60 TABLET (TABLET) in 1 BOTTLE None 3 NDC:16590-475-90 90 TABLET (TABLET) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070541 12/08/2009

Labeler — STAT RX USA LLC (786036330)

Establishment
Name	Address	ID/FEI	Operations
STAT RX USA LLC		786036330	repack, relabel

Revised: 03/2010 STAT RX USA LLC