Data / Drug companies / Rufinamide
Rufinamide: 12 companies and 24 products in the FDA NDC directory
Rufinamide is listed in the FDA National Drug Code Directory by 12 companies, with 24 products in commercial distribution. 21 of the products (87.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; suspension; tablet, and the newest product started marketing on January 6, 2026.
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- Companies listing it
- 12
- Products
- 24
- Generic (ANDA) products
- 21 (87.5%)
- Application numbers
- 15
- Routes
- Oral
- Brand names
- Banzel
- openFDA record search
- api.fda.gov
Companies that list rufinamide
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Aurobindo Pharma Limited | 3 | tablet, film coated; suspension | Generic drugs (ANDA) | June 16, 2023 |
| Camber Pharmaceuticals, Inc. | 3 | tablet, film coated; suspension | Generic drugs (ANDA) | December 5, 2023 |
| Eisai Inc. | 3 | tablet, film coated; suspension | New drug applications (NDA) | March 3, 2011 |
| Hikma Pharmaceuticals USA Inc. | 3 | tablet, film coated; suspension | Generic drugs (ANDA) | May 30, 2021 |
| Lupin Pharmaceuticals, Inc. | 3 | tablet, film coated; suspension | Generic drugs (ANDA) | June 22, 2023 |
| Glenmark Pharmaceuticals Inc., USA | 2 | tablet, film coated | Generic drugs (ANDA) | May 16, 2016 |
| Micro Labs Limited | 2 | tablet | Generic drugs (ANDA) | July 1, 2023 |
| American Health Packaging | 1 | suspension | Generic drugs (ANDA) | January 6, 2026 |
| Ascend Laboratories, LLC | 1 | suspension | Generic drugs (ANDA) | February 24, 2021 |
| Bionpharma Inc. | 1 | suspension | Generic drugs (ANDA) | December 19, 2018 |
| NorthStar RxLLC | 1 | suspension | Generic drugs (ANDA) | August 1, 2024 |
| Novadoz Pharmaceuticals LLC | 1 | suspension | Generic drugs (ANDA) | April 15, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 12 | 50% |
| Suspension | 10 | 41.7% |
| Tablet | 2 | 8.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 21 | 87.5% |
| New drug applications (NDA) | 3 | 12.5% |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.