Data / Drug companies / Sotalol hydrochloride
Sotalol hydrochloride: 25 companies and 77 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Sotalol hydrochloride is listed in the FDA National Drug Code Directory by 25 companies, with 77 products in commercial distribution. 69 of the products (89.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; injection; solution, and the newest product started marketing on November 1, 2025.
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- Companies listing it
- 25
- Products
- 77
- Generic (ANDA) products
- 69 (89.6%)
- Application numbers
- 11
- Routes
- Oral, Intravenous
- Brand names
- Sotalol, Betapace Af, Betapace, Sotylize
- openFDA record search
- api.fda.gov
Companies that list sotalol hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 11 | tablet | Generic drugs (ANDA) | November 1, 2025 |
| Apotex Corp. | 7 | tablet | Generic drugs (ANDA) | September 9, 2003 |
| Legacy Pharma USA Inc. | 6 | tablet | New drug applications (NDA) | September 1, 2016 |
| Aphena Pharma Solutions - Tennessee, LLC | 5 | tablet | Generic drugs (ANDA) | July 24, 2020 |
| Bryant Ranch Prepack | 5 | tablet | Generic drugs (ANDA) | July 24, 2020 |
| AiPing Pharmaceutical, Inc. | 4 | tablet | Generic drugs (ANDA) | November 1, 2025 |
| Oxford Pharmaceuticals, LLC | 4 | tablet | Generic drugs (ANDA) | July 24, 2020 |
| PD-Rx Pharmaceuticals, Inc. | 4 | tablet | Generic drugs (ANDA) | July 24, 2020 |
| Teva Pharmaceuticals USA, Inc. | 4 | tablet | Generic drugs (ANDA) | May 5, 2000 |
| Aurobindo Pharma Limited | 3 | tablet | Generic drugs (ANDA) | June 29, 2023 |
| Bryant Ranch Prepack | 3 | tablet | Generic drugs (ANDA) | July 24, 2020 |
| Epic Pharma, LLC | 3 | tablet | Generic drugs (ANDA) | January 4, 2016 |
| Unichem Pharmaceuticals (USA), Inc. | 3 | tablet | Generic drugs (ANDA) | December 15, 2017 |
| A-S Medication Solutions | 2 | tablet | Generic drugs (ANDA) | July 24, 2020 |
| AvPAK | 2 | tablet | Generic drugs (ANDA) | March 4, 2021 |
| Proficient Rx LP | 2 | tablet | Generic drugs (ANDA) | July 24, 2020 |
| Altathera Pharmaceuticals, LLC | 1 | injection | New drug applications (NDA) | October 15, 2015 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | March 11, 2014 |
| Azurity Pharmaceuticals, Inc. | 1 | solution | New drug applications (NDA) | March 1, 2015 |
| Cardinal Health 107, LLC | 1 | tablet | Generic drugs (ANDA) | March 11, 2014 |
| Golden State Medical Supply, Inc. | 1 | tablet | Generic drugs (ANDA) | September 26, 2002 |
| Major Pharmaceuticals | 1 | tablet | Generic drugs (ANDA) | February 1, 2003 |
| Northwind Health Company, LLC | 1 | tablet | Generic drugs (ANDA) | June 14, 2023 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | May 4, 2000 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | February 1, 2003 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 75 | 97.4% |
| Injection | 1 | 1.3% |
| Solution | 1 | 1.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 69 | 89.6% |
| New drug applications (NDA) | 8 | 10.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Antiarrhythmic | 77 |
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.