Topiramate (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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TOPIRAMATE topiramate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-963(NDC:68382-139)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 50 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS LACTOSE
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code ZD;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-963-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:45865-963-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078235 03/27/2009
Labeler — medsource pharmaceuticals (833685915)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
medsource pharmaceuticals 833685915 repack (45865-963)

Revised: 12/2019 medsource pharmaceuticals

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