Quick answers
- What is Rufinamide used for?
- The FDA-approved label (Banzel, Eisai Inc., December 15, 2022) says: “I NDICATIONS AND USAGE BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Rufinamide have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Rufinamide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Rufinamide been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started March 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Rufinamide?
- 12 companies list prescription products of Rufinamide in the FDA NDC Directory, including Camber Pharmaceuticals, Inc., Aurobindo Pharma Limited and Hikma Pharmaceuticals USA Inc..
What Rufinamide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
I NDICATIONS AND USAGE BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults
— FDA label: Banzel, Eisai Inc., effective December 15, 2022. Read the full label on DailyMed →
The FDA has 16 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 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Suspension · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 24 in the FDA NDC Directory |
| Brand names | Banzel |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| rufinamide 200 mg tablet | Generic | $0.9241 per tablet |
| rufinamide 200 mg tablet, film coated | Generic | $0.9241 per tablet |
| rufinamide 200 mg tablet, film coated | Brand: Banzel | $12.61 per tablet |
| rufinamide 40 mg/mL suspension | Generic | $0.2124 per mL |
| rufinamide 40 mg/mL suspension | Brand: Banzel | $3.65 per mL |
| rufinamide 400 mg tablet | Generic | $1.35 per tablet |
| rufinamide 400 mg tablet, film coated | Generic | $1.35 per tablet |
| rufinamide 400 mg tablet, film coated | Brand: Banzel | $25.18 per tablet |
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.
- Camber Pharmaceuticals, Inc.3 products
- Aurobindo Pharma Limited3 products
- Hikma Pharmaceuticals USA Inc.3 products
- Lupin Pharmaceuticals, Inc.3 products
- Eisai Inc.3 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Micro Labs Limited2 products
- Bionpharma Inc.1 product
- Novadoz Pharmaceuticals LLC1 product
- American Health Packaging1 product
- Ascend Laboratories, LLC1 product
- NorthStar RxLLC1 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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021911 BANZEL | Eisai Inc | November 14, 2008 | 9, latest November 28, 2019 2019: Labeling · 2016: Manufacturing (CMC) · 2015: Labeling |
| NDA201367 BANZEL | Eisai Inc | March 3, 2011 | 7, latest May 30, 2023 2023: Manufacturing (CMC) · 2019: Labeling · 2015: Manufacturing (CMC) |
Generic approvals (13)
- ANDA204988Hikma · May 16, 2016
- ANDA205075Glenmark Pharms Ltd · May 16, 2016
- ANDA207363Hikma · April 23, 2019
- ANDA211388Bionpharma · April 23, 2019
- ANDA213457Lupin · December 18, 2020
- ANDA213410Alkem Labs Ltd · February 23, 2021
- ANDA204993Hetero Labs Ltd III · May 11, 2021
- ANDA204964Lupin · August 17, 2022
- ANDA216549Aurobindo Pharma · October 26, 2022
- ANDA216688Micro Labs · May 15, 2023
- ANDA217230Aurobindo Pharma · June 16, 2023
- ANDA216841Hetero Labs Ltd III · December 5, 2023
- ANDA214817Msn · April 15, 2025
Shortage status
The FDA drug shortage list does not show these products.
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.
-
March 13, 2025 · Class II · Ongoing · D-0323-2025
CGMP Deviations
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# — Glenmark Pharmaceuticals Inc., USA
-
July 21, 2023 · Class II · Terminated · D-1087-2023
cGMP deviations: Batch was released prior to approval.
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08 — Aurobindo Pharma USA Inc.
-
July 21, 2023 · Class II · Terminated · D-1088-2023
cGMP deviations: Batch was released prior to approval.
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08 — Aurobindo Pharma USA Inc.
-
March 15, 2021 · Class II · Terminated · D-0472-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677 — Cardinal Health Inc.
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Banzel, Eisai Inc., effective December 15, 2022; 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 →