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 IMAGE
(click image for full-size original)

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

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