Zonisamide (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69097-861-07 Rx Only

Zonisamide

Capsules, USP

100 mg

PHARMACIST:

PLEASE DISPENSE THE ACCOMPANYING

MEDICATION GUIDE TO EACH PATIENT

100 Capsules

Cipla

image
(click image for full-size original)
ZONISAMIDE zonisamide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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
MICROCRYSTALLINE CELLULOSE
HYDROGENATED CASTOR OIL
GELATIN, UNSPECIFIED
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:69097-861-07 100 CAPSULE in 1 BOTTLE None
2 NDC:69097-861-12 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077869 07/13/2016
Labeler — Cipla USA Inc. (078719707)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceutical Inc 165104469 analysis (69097-861), manufacture (69097-861)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceutical Inc 080334903 analysis (69097-861), pack (69097-861)

Revised: 08/2020 Cipla USA Inc.

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