Medicine
Bosentan 125 mg tablet
Bosentan 125 mg tablet is a generic prescription medicine for oral use, made by 3 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°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Bosentan
- Brand
- Sold under the generic name
- Strength
- 125 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 60 tablets and 10 more
- Manufacturers
- Zydus LifesciencesIndiaSun Pharmaceutical IndustriesIndiaActavis Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C02KX01 Bosentan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 April 2019
- Identifiers
- RxCUI 349253, 656659DailyMed set ID 8444da17-6c31-492b-8842-93740f083d9d, 39b2a85f-4322-42d4-b420-1b1d52569143, c006d8ef-8cb7-4fb3-88eb-b2debc302a20 +1NDC 68382-447, 0591-2512, 47335-039 +1Application ANDA207760, ANDA207110, ANDA209324
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, coated in 1 bottle | 68382-447-01 | Zydus LifesciencesIndia | 1 May 2019 |
| 500 tablet, coated in 1 bottle | 68382-447-05 | Zydus LifesciencesIndia | 1 May 2019 |
| 60 tablet, coated in 1 bottle | 68382-447-14 | Zydus LifesciencesIndia | 1 May 2019 |
| 180 tablet, coated in 1 bottle | 68382-447-28 | Zydus LifesciencesIndia | 1 May 2019 |
| 10 blister pack in 1 carton / 10 tablet, coated in 1 blister pack | 68382-447-77 | Zydus LifesciencesIndia | 1 May 2019 |
| 100 tablet in 1 bottle | 70771-1018-1 | Zydus LifesciencesIndia | 1 May 2019 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1018-4 | Zydus LifesciencesIndia | 1 May 2019 |
| 500 tablet in 1 bottle | 70771-1018-5 | Zydus LifesciencesIndia | 1 May 2019 |
| 60 tablet in 1 bottle | 70771-1018-6 | Zydus LifesciencesIndia | 1 May 2019 |
| 180 tablet in 1 bottle | 70771-1018-8 | Zydus LifesciencesIndia | 1 May 2019 |
| 10 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 47335-039-64 | Sun Pharmaceutical IndustriesIndia | 26 April 2019 |
| 60 tablet, film coated in 1 bottle | 47335-039-86 | Sun Pharmaceutical IndustriesIndia | 26 April 2019 |
| 60 tablet, film coated in 1 bottle | 0591-2512-60 | Actavis Pharma | 19 June 2019 |
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.
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 Bosentan 125 mg tablet.
Other strengths and forms of Bosentan
Clinical summary
Bosentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1). It is available as tablets and tablet for oral suspension. MedsAcross supplies Bosentan 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 BosentanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tracleer prescribing information (Actelion Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Stayveer: European public assessment report (EPAR) · European Medicines Agency
- Tracleer: European public assessment report (EPAR) · European Medicines Agency
Need Bosentan 125 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.