Quick answers
- What is Orenitram?
- Orenitram is a brand name of Treprostinil, a prescription medicine. The FDA NDC Directory lists 5 Orenitram products in 5 strengths and forms.
- Who makes Orenitram?
- United Therap holds the FDA application for Orenitram (NDA203496, approved December 20, 2013).
- Is there a generic or store brand of Orenitram?
- Other products of Treprostinil are listed with the FDA, but none in exactly the same strength and form as a Orenitram product.
- Has Orenitram been recalled?
- No recall linked to Orenitram products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Orenitram is
Each Orenitram product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Treprostinil · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| treprostinil 0.125 mg tablet, extended release (oral) | Orenitram | None listed | DailyMed |
| treprostinil 0.25 mg tablet, extended release (oral) | Orenitram | None listed | DailyMed |
| treprostinil 1 mg tablet, extended release (oral) | Orenitram | None listed | DailyMed |
| treprostinil 2.5 mg tablet, extended release (oral) | Orenitram | None listed | DailyMed |
| treprostinil 5 mg tablet, extended release (oral) | Orenitram | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Treprostinil →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA203496 | United Therap | December 20, 2013 | 5 |
Companies that list Orenitram
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Orenitram products.
- United Therapeutics Corporation5 products
Recalls
No recall linked to Orenitram products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.