Medicine
Ambrisentan 5 mg tablet
Ambrisentan 5 mg tablet is a generic prescription medicine for oral use, made by 11 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), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Ambrisentan
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 1 blister pack and 22 more
- Manufacturers
- Zydus LifesciencesIndiaSun Pharmaceutical IndustriesIndiaCiplaIndiaAurobindo PharmaIndiaSigmapharm LaboratoriesA-S Medication SolutionsActavis PharmaApotexGolden State Medical SupplyMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store ambrisentan tablets in its original packaging.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C02KX02 Ambrisentan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 April 2019
- Identifiers
- RxCUI 722116, 722122DailyMed set ID 6fc6032f-94dc-4067-8b24-01990ec99db0, 4396bab5-2851-62ef-e063-6294a90af76e, 0e418384-cae1-47ae-ac5e-afc845d694f6 +9NDC 82009-141, 51407-594, 69097-386 +9Application ANDA210058, ANDA210701, ANDA210715 +5
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, film coated in 1 bottle | 70710-1179-1 | Zydus LifesciencesIndia | 12 April 2019 |
| 30 tablet, film coated in 1 bottle | 70710-1179-3 | Zydus LifesciencesIndia | 12 April 2019 |
| 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 70710-1179-7 | Zydus LifesciencesIndia | 12 April 2019 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 70710-1179-8 | Zydus LifesciencesIndia | 12 April 2019 |
| 90 tablet, film coated in 1 bottle | 70710-1179-9 | Zydus LifesciencesIndia | 12 April 2019 |
| 100 tablet, film coated in 1 bottle | 70771-1363-1 | Zydus LifesciencesIndia | 12 April 2019 |
| 30 tablet, film coated in 1 bottle | 70771-1363-3 | Zydus LifesciencesIndia | 12 April 2019 |
| 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 70771-1363-7 | Zydus LifesciencesIndia | 12 April 2019 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 70771-1363-8 | Zydus LifesciencesIndia | 12 April 2019 |
| 90 tablet, film coated in 1 bottle | 70771-1363-9 | Zydus LifesciencesIndia | 12 April 2019 |
| 30 tablet, film coated in 1 bottle | 59651-494-30 | Aurobindo PharmaIndia | 21 July 2022 |
| 30 tablet, film coated in 1 bottle, plastic | 69097-386-02 | CiplaIndia | 26 April 2019 |
| 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 69097-386-19 | CiplaIndia | 26 April 2019 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 47335-236-64 | Sun Pharmaceutical IndustriesIndia | 29 April 2019 |
| 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 47335-236-66 | Sun Pharmaceutical IndustriesIndia | 29 April 2019 |
| 30 tablet, film coated in 1 bottle | 47335-236-83 | Sun Pharmaceutical IndustriesIndia | 29 April 2019 |
| 10 tablet, film coated in 1 bottle | 47335-236-85 | Sun Pharmaceutical IndustriesIndia | 29 April 2019 |
| 30 tablet, film coated in 1 bottle | 0591-2405-30 | Actavis Pharma | 30 April 2019 |
| 30 tablet, film coated in 1 bottle | 60505-4552-3 | Apotex | 19 September 2022 |
| 30 tablet, film coated in 1 bottle, plastic | 0378-4270-93 | Mylan Pharmaceuticals | 29 April 2019 |
| 30 tablet, film coated in 1 bottle, plastic | 42794-051-08 | Sigmapharm Laboratories | 10 April 2019 |
| 10 tablet, film coated in 1 bottle, plastic | 42794-051-22 | Sigmapharm Laboratories | 10 April 2019 |
| 30 tablet, film coated in 1 bottle | 50090-7671-0 | A-S Medication Solutions | 7 October 2025 |
| 30 tablet, film coated in 1 bottle | 51407-594-30 | Golden State Medical Supply | 17 November 2025 |
| 30 tablet, film coated in 1 bottle | 82009-141-30 | Quallent Pharmaceuticals Health | 1 May 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.
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 Ambrisentan 5 mg tablet.
Other strengths and forms of Ambrisentan
Clinical summary
Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients. It is available as tablets for oral use. MedsAcross supplies Ambrisentan 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 AmbrisentanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Letairis prescribing information (Gilead Sciences) · U.S. National Library of Medicine, DailyMed
- Volibris: European public assessment report (EPAR) · European Medicines Agency
- Ambrisentan Viatris (previously Ambrisentan Mylan): European public assessment report (EPAR) · European Medicines Agency
Need Ambrisentan 5 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.