Active substance
Sotalol
- US FDA 23
- Health Canada 5
- US price lines 6
- NHS prices 3
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BETAPACE | 80MG; 160MG; 240MG; 120MG | tablet · oral | LEGACY | Prescription | 30 Oct 1992 |
| BETAPACE AF | 80MG; 120MG; 160MG | tablet · oral | LEGACY | Prescription | 22 Feb 2000 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG; 240MG | tablet · oral | TEVA | Prescription | 1 May 2000 |
| SORINE | 80MG; 160MG; 240MG; 120MG | tablet · oral | AIPING PHARM INC | Prescription | 27 Apr 2001 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG; 240MG | tablet · oral | APOTEX | Prescription | 26 Sep 2002 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG | tablet · oral | APOTEX | Prescription | 27 Aug 2003 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG; 240MG | tablet · oral | OXFORD PHARMS | Prescription | 7 Nov 2003 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG | tablet · oral | EPIC PHARMA LLC | Prescription | 4 Nov 2005 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG | tablet · oral | AUROBINDO PHARMA USA | Prescription | 7 Feb 2007 |
| SOTALOL HYDROCHLORIDE | 150MG/10ML (15MG/ML) | solution · intravenous | ALTATHERA PHARMS LLC | Prescription | 2 Jul 2009 |
| SOTYLIZE | 5MG/ML (5MG/ML) | solution · oral | AZURITY | Prescription | 22 Oct 2014 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG | tablet · oral | REGCON HOLDINGS | Prescription | 21 Oct 2016 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG | tablet · oral | REGCON HOLDINGS | Prescription | 2 Nov 2018 |
| BETAPACE | 320MG | tablet · oral | LEGACY | Discontinued | 30 Oct 1992 |
| BETAPACE AF | 100MG; 40MG; 60MG | tablet · oral | LEGACY | Discontinued | 22 Feb 2000 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG; 240MG | tablet · oral | NOVITIUM PHARMA | Discontinued | 1 May 2000 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG; 240MG | tablet · oral | UPSHER SMITH LABS | Discontinued | 1 May 2000 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG; 240MG | tablet · oral | WATSON LABS | Discontinued | 13 Jul 2000 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG; 240MG | tablet · oral | IMPAX PHARMS | Discontinued | 7 Nov 2000 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG; 240MG | tablet · oral | RISING | Discontinued | 19 Dec 2000 |
| SOTALOL HYDROCHLORIDE | 80MG; 160MG; 240MG; 120MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 15 Oct 2001 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 8 Apr 2004 |
| SOTALOL HYDROCHLORIDE | 80MG; 120MG; 160MG | tablet · oral | TEVA | Discontinued | 26 Jul 2004 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AMB-SOTALOL | 02565404 | 80 MG | TABLET · ORAL | AMBICARE PHARMACEUTICALS INC. |
| AMB-SOTALOL | 02565412 | 160 MG | TABLET · ORAL | AMBICARE PHARMACEUTICALS INC. |
| APO-SOTALOL | 02167794 | 160 MG | TABLET · ORAL | APOTEX INC |
| APO-SOTALOL | 02210428 | 80 MG | TABLET · ORAL | APOTEX INC |
| PMS-SOTALOL - 80 MG | 02238326 | 80 MG | TABLET · ORAL | PHARMASCIENCE INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | SOTALOL 120 MG TABLET | $0.11009 | per EA | 23 Sep 2026 |
| US NADAC | SOTALOL 160 MG TABLET | $0.12996 | per EA | 23 Sep 2026 |
| US NADAC | SOTALOL 240 MG TABLET | $0.20056 | per EA | 23 Sep 2026 |
| US NADAC | SOTALOL 80 MG TABLET | $0.07066 | per EA | 23 Sep 2026 |
| US NADAC | SOTYLIZE 5 MG/ML ORAL SOLUTION | $2.31744 | per ML | 23 Sep 2026 |
| US NADAC | SOTYLIZE 5 MG/ML ORAL SOLUTION | $2.32452 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Sotalol 160mg tablets | £9.42 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Sotalol 40mg tablets | £3.11 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Sotalol 80mg tablets | £5.92 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 23 Jul 2025 SOTALOL HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 12 Jan 2024 SOTYLIZE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 15 Jun 2023 BETAPACE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.