Quick answers
- What is Treprostinil used for?
- The FDA-approved label (Remodulin, United Therapeutics Corporation, July 2, 2026) says: “Remodulin is a prostacyclin mimetic indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Treprostinil have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Treprostinil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Treprostinil been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 14, 2018 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Treprostinil?
- 6 companies list prescription products of Treprostinil in the FDA NDC Directory, including United Therapeutics Corporation, Sandoz Inc and Dr. Reddy's Laboratories Inc..
What Treprostinil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Remodulin is a prostacyclin mimetic indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue …
— FDA label: Remodulin, United Therapeutics Corporation, effective July 2, 2026. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Inhalant · Tablet, extended release · Injection · Capsule |
|---|---|
| Route | Intravenous · Subcutaneous · Oral · Respiratory (inhalation) |
| Prescription products | 41 in the FDA NDC Directory |
| Brand names | Tyvaso Dpi, Remodulin, Orenitram, Yutrepia, Tyvaso |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- United Therapeutics Corporation21 products
- Sandoz Inc4 products
- Dr. Reddy's Laboratories Inc.4 products
- Alembic Pharmaceuticals Inc.4 products
- Teva Parenteral Medicines, Inc.4 products
- Liquidia Technologies, Inc.4 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021272 REMODULIN | United Therap | May 21, 2002 | 15, latest March 7, 2023 2023: Labeling · 2021: Manufacturing (CMC) · 2018: Labeling |
| NDA022387 TYVASO | United Therap | July 30, 2009 | 11, latest April 3, 2026 2026: Labeling · 2022: Labeling · 2021: Efficacy |
| NDA203496 ORENITRAM | United Therap | December 20, 2013 | 7, latest August 4, 2026 2026: Manufacturing (CMC) · 2020: Manufacturing (CMC) · 2019: Efficacy |
| NDA213005 YUTREPIA | Liquidia Tech | May 23, 2025 | — |
| NDA214324 TYVASO DPI | United Therap | May 23, 2022 | 1, latest September 23, 2026 2026: Labeling |
Generic approvals (4)
- ANDA203649Sandoz · November 30, 2017
- ANDA206648Teva Pharms USA · September 26, 2019
- ANDA210214DR Reddys · May 22, 2020
- ANDA211574Alembic Global · February 11, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: 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.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 349407, 349408, 349409, 349410, 352211, 352212, 352213, 352214, 857795, 857799 … (+10) |
|---|---|
| SPL set ID of the quoted label | 6c80bb38-e8db-4138-9f0d-dbbf9c673185 |
| FDA labels (SPL) | 9 |
| FDA applications | NDA021272, NDA022387, NDA203496, NDA213005, NDA214324, 4 ANDA |
| Active ingredients (FDA) | TREPROSTINIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Remodulin, United Therapeutics Corporation, effective July 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →