Data / Drug companies / Dofetilide
Dofetilide: 12 companies and 35 products in the FDA NDC directory
Dofetilide is listed in the FDA National Drug Code Directory by 12 companies, with 35 products in commercial distribution. 32 of the products (91.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, and the newest product started marketing on August 26, 2026.
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- Companies listing it
- 12
- Products
- 35
- Generic (ANDA) products
- 32 (91.4%)
- Application numbers
- 9
- Routes
- Oral
- Brand names
- Tikosyn
- openFDA record search
- api.fda.gov
Companies that list dofetilide
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Accord Healthcare Inc. | 3 | capsule | Generic drugs (ANDA) | August 20, 2020 |
| Aurobindo Pharma Limited | 3 | capsule | Generic drugs (ANDA) | January 22, 2019 |
| Bionpharma Inc. | 3 | capsule | Generic drugs (ANDA) | April 11, 2018 |
| Dr. Reddy's Laboratories Inc. | 3 | capsule | Generic drugs (ANDA) | May 28, 2024 |
| Exelan Pharmaceuticals Inc. | 3 | capsule | Generic drugs (ANDA) | November 1, 2024 |
| Major Pharmaceuticals | 3 | capsule | Generic drugs (ANDA) | October 17, 2024 |
| NorthStar RxLLC | 3 | capsule | Generic drugs (ANDA) | February 7, 2023 |
| Novadoz Pharmaceuticals LLC | 3 | capsule | Generic drugs (ANDA) | June 12, 2020 |
| Pfizer Laboratories Div Pfizer Inc | 3 | capsule | New drug applications (NDA) | October 1, 1999 |
| Sigmapharm Laboratories, LLC | 3 | capsule | Generic drugs (ANDA) | June 11, 2018 |
| Sun Pharmaceutical Industries, Inc. | 3 | capsule | Generic drugs (ANDA) | October 11, 2018 |
| Remedyrepack Inc. | 2 | capsule | Generic drugs (ANDA) | August 26, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 35 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 32 | 91.4% |
| New drug applications (NDA) | 3 | 8.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Antiarrhythmic | 35 |
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.