Quick answers
- What is Epoprostenol used for?
- The FDA-approved label (Veletri, Actelion Pharmaceuticals US, Inc., November 28, 2022) says: “VELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Epoprostenol have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Epoprostenol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Epoprostenol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Epoprostenol?
- 4 companies list prescription products of Epoprostenol in the FDA NDC Directory, including Mylan Institutional LLC, Gland Pharma Limited and Actelion Pharmaceuticals US, Inc..
What Epoprostenol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. …
— FDA label: Veletri, Actelion Pharmaceuticals US, Inc., effective November 28, 2022. Read the full label on DailyMed →
The FDA has 4 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 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Veletri |
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.
- Mylan Institutional LLC2 products
- Gland Pharma Limited2 products
- Actelion Pharmaceuticals US, Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 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 |
|---|---|---|---|
| NDA022260 VELETRI | Actelion | June 27, 2008 | 7, latest October 21, 2020 2020: Labeling · 2018: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (3)
- ANDA210473Sun Pharm · January 15, 2021
- ANDA213913Mylan · June 12, 2024
- ANDA219237Gland · December 29, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 562501, 562502, 1009216, 1302755 |
|---|---|
| SPL set ID of the quoted label | df502787-46ec-4dd1-a2c0-be90f6d95a5d |
| FDA labels (SPL) | 4 |
| FDA applications | NDA022260, 3 ANDA |
| Active ingredients (FDA) | EPOPROSTENOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Veletri, Actelion Pharmaceuticals US, Inc., effective November 28, 2022; 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 →