Medicine
Epoprostenol 0.5 mg/10 mL powder for injection
Epoprostenol 0.5 mg/10 mL powder for injection is a generic prescription medicine for intravenous 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 the vials of Epoprostenol for Injection at 20° to 25°C (68° to 77°F)…
Key facts
- Active ingredient (INN)
- Epoprostenol
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/10 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Manufacturers
- Gland PharmaIndiaSun Pharmaceutical IndustriesIndiaMylan Institutional
- Origin register
- US FDA, United States
- Storage
- Store the vials of Epoprostenol for Injection at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Storage and Stability Unopened vials of Epoprostenol for Injection are stable until the date indicated on the package when stored at 68° to 77°F (20° to 25°C). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AC09 Epoprostenol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 January 2021
- Identifiers
- RxCUI 562501, 562502DailyMed set ID 47f64fcd-cbf7-457a-9548-661fb10ff7e0, 2a163b77-9e01-4516-b19c-f5a12ce48560, db57e498-db20-45e8-8298-b0cf0811d270NDC 68083-707, 67457-587, 62756-059Application ANDA219237, ANDA213913, ANDA210473
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 |
|---|---|---|---|
| 1 vial in 1 carton / 10 mL in 1 vial | 68083-707-01 | Gland PharmaIndia | 29 December 2025 |
| 1 vial in 1 carton / 10 mL in 1 vial | 62756-059-40 | Sun Pharmaceutical IndustriesIndia | 16 January 2021 |
| 1 vial in 1 carton / 10 mL in 1 vial | 67457-587-10 | Mylan Institutional | 25 September 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 20 September 1995 | 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 Epoprostenol 0.5 mg/10 mL powder for injection.
Other strengths and forms of Epoprostenol
Clinical summary
Epoprostenol is a prostacycline vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. It is available as powder for injection for intravenous use. MedsAcross supplies Epoprostenol 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 EpoprostenolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Veletri prescribing information (Actelion Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Epoprostenol 0.5 mg/10 mL powder for injection 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.