Medicine
Sotylize 5 mg/mL oral solution
Sotylize 5 mg/mL oral solution is a prescription medicine containing Sotalol for oral use, marketed by Azurity Pharmaceuticals, 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°C to 25°C (68°F -77°F), excursions permitted between 15°C and 30°C…
Key facts
- Active ingredient (INN)
- Sotalol
- Brand
- Sotylize
- Strength
- 5 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 250 mL, 480 mL
- Marketing authorisation holder
- Azurity Pharmaceuticals
- Manufacturer
- Azurity Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F -77°F), excursions permitted between 15°C and 30°C (59°F-86°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
- 1 March 2015
- Identifiers
- RxCUI 1593725, 1593731DailyMed set ID 1f33f900-0777-4a92-a7f7-00cf3d57d95cNDC 24338-530Application NDA205108
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 250 mL in 1 bottle | 24338-530-25 | Azurity Pharmaceuticals | 1 March 2015 |
| 480 mL in 1 bottle | 24338-530-48 | Azurity Pharmaceuticals | 1 March 2015 |
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
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 Sotylize 5 mg/mL oral solution 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.