Medicine
Orenitram 5 mg extended-release tablet
Orenitram 5 mg extended-release tablet is a prescription medicine containing Treprostinil for oral use, marketed by United Therapeutics, 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) with excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Treprostinil
- Brand
- Orenitram
- Strength
- 5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 1 blister pack
- Marketing authorisation holder
- United Therapeutics
- Manufacturer
- United Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AC21 Treprostinil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 December 2013
- Identifiers
- RxCUI 1488665, 1488667, 1488670 +7DailyMed set ID 8ed2003a-c801-411e-831e-d06079bb0d7cNDC 66302-350Application NDA203496
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 |
|---|---|---|---|
| 100 tablet, extended release in 1 bottle | 66302-350-01 | United Therapeutics | 20 December 2013 |
| 1 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 66302-350-02 | United Therapeutics | 30 June 2021 |
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
Other strengths and forms of Treprostinil
Clinical summary
Treprostinil is a prostacycline vasodilator indicated for treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to diminish symptoms associated with exercise, among other approved uses. MedsAcross supplies Treprostinil 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 TreprostinilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Remodulin prescribing information (United Therapeutics) · U.S. National Library of Medicine, DailyMed
- Trepulmix: European public assessment report (EPAR) · European Medicines Agency
Need Orenitram 5 mg extended-release 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.