Does Zonisamide have a boxed warning?

No. None of the 29 FDA labels we found for this medicine has a boxed warning.

Is there a shortage of Zonisamide?

No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).

Has Zonisamide been recalled?

FDA enforcement reports list 5 recalls of products of this medicine; the newest started April 25, 2022 (Class II). A recall usually concerns specific lots, not every product.

Who makes Zonisamide?

21 companies list prescription products of Zonisamide in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Aurobindo Pharma Limited.

Zonisamide (Zonegran, Zonisade): uses, warnings, recalls

Quick answers

What is Zonisamide used for?: The FDA-approved label (Zonisade, Azurity Pharmaceuticals, Inc., September 8, 2025) says: “ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years and older. ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Zonisamide have a boxed warning?: No. None of the 29 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Zonisamide?: No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Zonisamide been recalled?: FDA enforcement reports list 5 recalls of products of this medicine; the newest started April 25, 2022 (Class II). A recall usually concerns specific lots, not every product.
Who makes Zonisamide?: 21 companies list prescription products of Zonisamide in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Aurobindo Pharma Limited.

What Zonisamide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years and older. ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.

— FDA label: Zonisade, Azurity Pharmaceuticals, Inc., effective September 8, 2025. Read the full label on DailyMed →

The FDA has 29 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 29 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage forms	Capsule · Suspension
Route	Oral
Prescription products	51 in the FDA NDC Directory
Brand names	Zonegran, Zonisade

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Zonisamide, by strength and form
Strength and form	Generic or brand	Pharmacies pay
zonisamide 100 mg capsule	Generic	$0.1051 per capsule
zonisamide 100 mg/5 mL suspension	Brand: Zonisade	$2.75 per mL
zonisamide 25 mg capsule	Generic	$0.0685 per capsule
zonisamide 50 mg capsule	Generic	$0.0936 per capsule

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

Bryant Ranch Prepack7 products
Remedyrepack Inc.4 products
Aurobindo Pharma Limited3 products
Viona Pharmaceuticals Inc3 products
Exelan Pharmaceuticals Inc.3 products
Proficient Rx LP3 products
Zydus Lifesciences Limited3 products
Unichem Pharmaceuticals (USA), Inc.3 products
Sun Pharmaceutical Industries, Inc.3 products
Glenmark Pharmaceuticals Inc., USA3 products
BluePoint Laboratories3 products
Direct_Rx2 products
Advanz Pharma (US) Corp.2 products
Preferred Pharmaceuticals Inc.2 products
NCS HealthCare of KY, LLC dba Vangard Labs1 product
Advanced Rx Pharmacy of Tennessee, LLC1 product
Advanced Rx of Tennessee, LLC1 product
American Health Packaging1 product
Azurity Pharmaceuticals, Inc.1 product
Cipla USA Inc.1 product
AvPAK1 product

FDA approval history

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
ANDA: Abbreviated New Drug Application: how a generic version is approved.

Brand and biologic applications
Application	Sponsor	Approved	Later changes approved
NDA020789 ZONEGRAN	Advanz Pharma	March 27, 2000	21, latest April 13, 2020 2020: Labeling · 2016: Labeling · 2015: Manufacturing (CMC)
NDA214273 ZONISADE	Azurity	July 15, 2022	—

Generic approvals (6)

ANDA077645Aurobindo Pharma Ltd · December 22, 2005
ANDA077651Glenmark Pharms · January 30, 2006
ANDA077634Sun Pharm Inds (In) · March 17, 2006
ANDA077869Invagen Pharms · May 31, 2006
ANDA077625Zydus Lifesciences · October 16, 2006
ANDA214492Unichem · January 26, 2021

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

April 25, 2022 · Class II · Completed · D-0792-2022

cGMP deviations

Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 6 — Glenmark Pharmaceuticals Inc., USA
April 25, 2022 · Class II · Completed · D-0793-2022

cGMP deviations

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured — Glenmark Pharmaceuticals Inc., USA
April 25, 2022 · Class II · Completed · D-0791-2022

cGMP deviations

Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68 — Glenmark Pharmaceuticals Inc., USA
August 27, 2021 · Class II · Terminated · D-0826-2021

CGMP Deviations

Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 C — Glenmark Pharmaceuticals Inc., USA
August 27, 2021 · Class II · Terminated · D-0825-2021

CGMP Deviations

Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 — Glenmark Pharmaceuticals Inc., USA

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)	314285, 403966, 403967, 2606782, 2606788
SPL set ID of the quoted label	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6
FDA labels (SPL)	29
FDA applications	NDA020789, NDA214273, 6 ANDA
Active ingredients (FDA)	ZONISAMIDE

Sources

FDA-approved label on DailyMed (National Library of Medicine) — Zonisade, Azurity Pharmaceuticals, Inc., effective September 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers

Zonisamide

Official FDA data, not advice

At a glance