Quick answers
- What is Tyvaso?
- Tyvaso is a brand name of Treprostinil, a prescription medicine. The FDA NDC Directory lists 1 Tyvaso product in 1 strength and form.
- Who makes Tyvaso?
- United Therap holds the FDA application for Tyvaso (NDA022387, approved July 30, 2009).
- Is there a generic or store brand of Tyvaso?
- Other products of Treprostinil are listed with the FDA, but none in exactly the same strength and form as a Tyvaso product.
- Has Tyvaso been recalled?
- FDA enforcement reports list 1 recall of Tyvaso products; the newest started August 14, 2018. A recall usually concerns specific lots, not every product.
What Tyvaso is
Each Tyvaso 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 1.74 mg/2.9 mL inhalant (oral) | Tyvaso | 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 |
|---|---|---|---|
| NDA022387 | United Therap | July 30, 2009 | 1 |
Companies that list Tyvaso
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tyvaso products.
- United Therapeutics Corporation1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 14, 2018 · Class III · Terminated · D-1188-2018
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Onl — United Therapeutics Corp.
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.