Drug
Who makes sotalol hydrochloride?
21 companies list sotalol hydrochloride as a human prescription drug, including under the names BETAPACE, BETAPACE AF, SOTYLIZE. Forms: injection; solution; tablet. Routes: intravenous, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing sotalol hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA075500, ANDA075563, ANDA076140 | 19 | 1 |
| Apotex Inc.Canada | tablet | ANDAANDA076140, ANDA076214 | 7 | 6 |
| Legacy Pharma USA Inc.United States | tablet | NDANDA019865 | 6 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet | ANDAANDA075429, ANDA075563, ANDA076140 | 5 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet | ANDAANDA075429 | 4 | 6 |
| AiPing Pharmaceutical, Inc.United States | tablet | ANDAANDA075500 | 4 | 1 |
| Oxford Pharmaceuticals, LLCUnited States | tablet | ANDAANDA075563 | 4 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA075563 | 4 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA075429, ANDA075563, ANDA076140 | 4 | 1 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA077616 | 3 | 6 |
| Unichem Laboratories Limited, IndiaIndia | tablet | ANDAANDA207428 | 3 | 5 |
| Epic Laboratories, LLCUnited States | tablet | ANDAANDA077070 | 3 | 3 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA075563, ANDA076140 | 2 | 3 |
| AvPAK | tablet | ANDAANDA076140 | 2 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA076140 | 1 | 34 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA076140 | 1 | 5 |
| AltaThera Pharmaceuticals LLCUnited States | injection | NDANDA022306 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA076140 | 1 | 1 |
| Northwind Health Company, LLCUnited States | tablet | ANDAANDA076140 | 1 | 1 |
| Azurity Pharmaceuticals, Inc. | solution | NDANDA205108 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA076140 | 1 | 0 |
Bulk ingredient listings
- CAMBREX PROFARMACO MILANO SRLItaly · 1 NDC
- Moehs Catalana SLSpain · 1 NDC
- Neuland Laboratories LimitedIndia · 1 NDC
Orange Book patents
12 unexpired patents list sotalol hydrochloride as the active ingredient, expiring between Aug 2028 and Aug 2039. Application holders: ALTATHERA PHARMACEUTICALS LLC, AZURITY PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes sotalol hydrochloride?
- 21 companies list sotalol hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Apotex Inc., Legacy Pharma USA Inc., Aphena Pharma Solutions - Tennessee, LLC, Teva Pharmaceutical Industries Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic BETAPACE?
- 18 companies list sotalol hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies sotalol hydrochloride active ingredient?
- 3 companies list sotalol hydrochloride as a bulk ingredient, including CAMBREX PROFARMACO MILANO SRL, Moehs Catalana SL, Neuland Laboratories Limited.