Zonisamide (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-816-15
Zonisamide Capsules USP
100 mg
Rx Only
50 Capsules (5 X 10) Unit Dose
5026881615
NDC 50268-816-15
Zonisamide Capsules USP
100 mg
Rx Only
50 Capsules (5 X 10) Unit Dose
5026881615

PHARMACIST: Please dispense the accompanying medication guide to each patient.
Each capsule contains 100 mg of zonisamide USP

USUAL DOSAGE: Please refer to package insert for full prescribing information.
Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature] in a dry place and protected from light.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT OF AvKARE
Mfg. Rev. 01/12 AV 07/14 (P)

label
(click image for full-size original)
ZONISAMIDE zonisamide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-816(NDC:69097-861)
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
HYDROGENATED CASTOR OIL
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color brown (brown opaque cap and white opaque body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code IG;228
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-816-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-816-11)
1 NDC:50268-816-11 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (50268-816-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077869 07/02/2014
Labeler — AvPAK (832926666)

Revised: 01/2022 AvPAK

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