Quick answers
- What is Remodulin?
- Remodulin is a brand name of Treprostinil, a prescription medicine. The FDA NDC Directory lists 5 Remodulin products in 5 strengths and forms.
- Who makes Remodulin?
- United Therap holds the FDA application for Remodulin (NDA021272, approved May 21, 2002).
- Is there a generic or store brand of Remodulin?
- Yes. The FDA NDC Directory lists 12 other products with the same active ingredients, strength and form as a Remodulin product, 12 of them generic. Ask your pharmacist whether one is right for you.
- Has Remodulin been recalled?
- No recall linked to Remodulin products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Remodulin is
Each Remodulin 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 100 mg/20 mL injection, solution (intravenous, subcutaneous) | Remodulin | 3 products, 3 companies | DailyMed |
| treprostinil 20 mg/20 mL injection, solution (intravenous, subcutaneous) | Remodulin | 3 products, 3 companies | DailyMed |
| treprostinil 200 mg/20 mL injection, solution (intravenous, subcutaneous) | Remodulin | 3 products, 3 companies | DailyMed |
| treprostinil 50 mg/20 mL injection, solution (intravenous, subcutaneous) | Remodulin | 3 products, 3 companies | DailyMed |
| treprostinil 8 mg/20 mL injection, solution (intravenous, subcutaneous) | Remodulin | 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 |
|---|---|---|---|
| NDA021272 | United Therap | May 21, 2002 | 5 |
Companies that list Remodulin
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Remodulin products.
- United Therapeutics Corporation5 products
Recalls
No recall linked to Remodulin 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.