Zonisamide (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

Zonisamide Capsules
50 mg
Rx onlyPHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY

image of 50 mg package label
(click image for full-size original)

Zonisamide Capsules
100 mg
Rx only
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY

image of 100 mg package label
(click image for full-size original)
ZONISAMIDE zonisamide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6221(NDC:62756-259)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZONISAMIDE (ZONISAMIDE) ZONISAMIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
GELATIN
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color white (white opaque) , gray (light gray opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 259;259
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6221-0 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077634 12/29/2010
ZONISAMIDE zonisamide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5789(NDC:62756-260)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZONISAMIDE (ZONISAMIDE) ZONISAMIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
Product Characteristics
Color white (white opaque) , orange (swedish orange opaque) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 260;260
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5789-0 30 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5789-1 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077634 07/11/2007
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 01/2011 Physicians Total Care, Inc.

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