Sotalol 80 mg tablet is a generic prescription medicine for oral use, made by 17 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Sotalol
- Brand
- Sold under the generic name
- Strength
- 80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 61 more
- Manufacturers
- Unichem LaboratoriesIndiaAurobindo PharmaIndiaBryant Ranch PrepackAphena Pharma Solutions - TennesseeApotexEpic PharmaOxford PharmaceuticalsAiPing PharmaceuticalTeva Pharmaceuticals17 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C07AA07 Sotalol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 May 2000
- Identifiers
- RxCUI 1923426, 904589, 1922720 +4DailyMed set ID d6c8f659-1c32-4431-bdb2-3211a1c81006, 7cb4879f-31e7-4862-bc0c-d439e592d81c, bbeaba9f-0513-4980-bc29-7f9259a53ecc +29NDC 71335-2823, 50090-1299, 50090-7796 +31Application ANDA075563, ANDA076140, ANDA075429 +6
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 17 labelers. The register lists 64 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle, plastic | 76385-114-01 | Unichem LaboratoriesIndia | 15 December 2017 |
| 500 tablet in 1 bottle, plastic | 76385-114-50 | Unichem LaboratoriesIndia | 15 December 2017 |
| 100 tablet in 1 bottle, plastic | 76385-125-01 | Unichem LaboratoriesIndia | 21 February 2020 |
| 500 tablet in 1 bottle, plastic | 76385-125-50 | Unichem LaboratoriesIndia | 21 February 2020 |
| 100 tablet in 1 bottle | 59651-775-01 | Aurobindo PharmaIndia | 29 June 2023 |
| 100 tablet in 1 bottle | 60505-0080-0 | Apotex | 1 February 2003 |
| 100 tablet in 1 bottle, plastic | 60505-0222-1 | Apotex | 9 September 2003 |
| 1000 tablet in 1 bottle, plastic | 60505-0222-2 | Apotex | 9 September 2003 |
| 100 tablet in 1 bottle | 11788-051-01 | AiPing Pharmaceutical | 1 November 2025 |
| 100 tablet in 1 bottle | 42806-121-01 | Epic Pharma | 4 January 2016 |
| 1000 tablet in 1 bottle | 42806-121-10 | Epic Pharma | 4 January 2016 |
| 100 tablet in 1 bottle | 69584-841-10 | Oxford Pharmaceuticals | 24 July 2020 |
| 500 tablet in 1 bottle | 69584-841-50 | Oxford Pharmaceuticals | 24 July 2020 |
| 100 tablet in 1 bottle | 0093-1061-01 | Teva Pharmaceuticals | 4 May 2000 |
| 100 tablet in 1 bottle | 63629-2422-1 | Bryant Ranch Prepack | 24 July 2020 |
| 60 tablet in 1 bottle | 71335-0260-1 | Bryant Ranch Prepack | 14 July 2020 |
| 30 tablet in 1 bottle | 71335-0260-2 | Bryant Ranch Prepack | 14 July 2020 |
| 100 tablet in 1 bottle | 71335-0260-3 | Bryant Ranch Prepack | 30 October 2024 |
| 90 tablet in 1 bottle | 71335-0260-4 | Bryant Ranch Prepack | 30 October 2024 |
| 60 tablet in 1 bottle | 71335-1189-1 | Bryant Ranch Prepack | 15 April 2019 |
| 30 tablet in 1 bottle | 71335-1189-2 | Bryant Ranch Prepack | 22 April 2019 |
| 100 tablet in 1 bottle | 71335-1189-3 | Bryant Ranch Prepack | 17 May 2024 |
| 90 tablet in 1 bottle | 71335-1189-4 | Bryant Ranch Prepack | 17 May 2024 |
| 60 tablet in 1 bottle | 71335-1917-1 | Bryant Ranch Prepack | 6 July 2022 |
| 30 tablet in 1 bottle | 71335-1917-2 | Bryant Ranch Prepack | 22 July 2021 |
| 100 tablet in 1 bottle | 71335-1917-3 | Bryant Ranch Prepack | 22 July 2021 |
| 90 tablet in 1 bottle | 71335-1917-4 | Bryant Ranch Prepack | 6 July 2022 |
| 100 tablet in 1 bottle | 71335-2823-1 | Bryant Ranch Prepack | 10 November 2025 |
| 100 tablet in 1 bottle | 72162-1931-1 | Bryant Ranch Prepack | 24 July 2020 |
| 100 tablet in 1 bottle | 72162-2118-1 | Bryant Ranch Prepack | 1 February 2003 |
| 100 tablet in 1 bottle | 72162-2524-1 | Bryant Ranch Prepack | 15 December 2017 |
| 100 tablet in 1 bottle | 72162-2583-1 | Bryant Ranch Prepack | 24 November 2025 |
| 30 tablet in 1 bottle, plastic | 71610-074-30 | Aphena Pharma Solutions - Tennessee | 21 May 2018 |
| 90 tablet in 1 bottle, plastic | 71610-074-60 | Aphena Pharma Solutions - Tennessee | 21 May 2018 |
| 90 tablet in 1 bottle | 71610-474-60 | Aphena Pharma Solutions - Tennessee | 25 January 2022 |
| 180 tablet in 1 bottle | 71610-474-80 | Aphena Pharma Solutions - Tennessee | 15 October 2020 |
| 30 tablet in 1 bottle | 71610-723-30 | Aphena Pharma Solutions - Tennessee | 7 August 2023 |
| 90 tablet in 1 bottle | 71610-723-60 | Aphena Pharma Solutions - Tennessee | 7 August 2023 |
| 180 tablet in 1 bottle | 71610-723-80 | Aphena Pharma Solutions - Tennessee | 7 August 2023 |
| 180 tablet in 1 bottle | 71610-849-80 | Aphena Pharma Solutions - Tennessee | 7 August 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 30 October 1992 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Sotalol 80 mg tablet.
Other strengths and forms of Sotalol
Clinical summary
Sotalol is an antiarrhythmic indicated for the treatment of life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL), among other approved uses. MedsAcross supplies Sotalol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about SotalolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BETAPACE prescribing information (Legacy Pharma) · U.S. National Library of Medicine, DailyMed
Need Sotalol 80 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.