Prescription Drug Information: Zonisamide (Page 6 of 6)

HOW SUPPLIED

Zonisamide capsules are available as 25 mg, 50 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with product code on cap and body “258”, “259” and “260”, respectively.

100 mg White opaque body with light swedish orange opaque cap.

NDC: 70518-1701-00

PACKAGING: 90 in 1 BOTTLE PLASTIC

Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Zonisamide

GENERIC: Zonisamide

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-1701-0

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 20 mm

IMPRINT: 260;260

PACKAGING: 90 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • ZONISAMIDE 100mg in 1

INACTIVE INGREDIENT(S):

  • MICROCRYSTALLINE CELLULOSE
  • GELATIN, UNSPECIFIED
  • TITANIUM DIOXIDE
  • FERROSOFERRIC OXIDE
  • SHELLAC
  • PROPYLENE GLYCOL
  • FD&C BLUE NO. 2
  • FD&C RED NO. 40
  • FD&C BLUE NO. 1
  • D&C YELLOW NO. 10
  • AMMONIA
  • POTASSIUM HYDROXIDE
Remedy_Label
(click image for full-size original)
ZONISAMIDE zonisamide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1701(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
MICROCRYSTALLINE CELLULOSE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
SHELLAC
PROPYLENE GLYCOL
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C BLUE NO. 1
D&C YELLOW NO. 10
AMMONIA
POTASSIUM HYDROXIDE
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:70518-1701-0 90 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077634 11/29/2018
Labeler — REMEDYREPACK INC. (829572556)

Revised: 06/2021 REMEDYREPACK INC.

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