NDC Code(s) : 0832-0611-15
Packager : Upsher-Smith Laboratories, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CarbamazepineCarbamazepine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0832-0611
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbamazepine(UNII: 33CM23913M)
(Carbamazepine - UNII:33CM23913M) 		Carbamazepine200 mg
Inactive Ingredients
Ingredient Name Strength
starch, corn(UNII: O8232NY3SJ)
croscarmellose sodium(UNII: M28OL1HH48)
diethyl phthalate(UNII: UF064M00AF)
magnesium stearate(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code CMZ;200;U;S
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0832-0611-15500 in 1 BOTTLE Type 0: Not a Combination Product03/10/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074649 10/03/1996 06/30/2017

PRINCIPAL DISPLAY PANEL

UPSHER-SMITH

NDC 0832-0611-15

Carbamazepine
Tablets, USP

200 mg

Dispense the
accompanying
Medication Guide
to each Patient

500 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label