Drug company (FDA labeler)
Actelion Pharmaceuticals US, Inc.
NDC labeler code: 66215
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- SelexipagUptravi · 11 products
- BosentanTracleer · 3 products
- Macitentan and tadalafilOpsynvi · 2 products
- EpoprostenolVeletri · 2 products
- MiglustatYargesa, Zavesca, Opfolda · 1 product
- MacitentanOpsumit · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 22, 2024 | NDA218490 | Macitentan and tadalafil OPSYNVI | Actelion |
| July 29, 2021 | NDA214275 | Selexipag UPTRAVI | Actelion |
| September 5, 2017 | NDA209279 | Bosentan TRACLEER | Actelion |
| December 21, 2015 | NDA207947 | Selexipag UPTRAVI | Actelion |
| October 18, 2013 | NDA204410 | Macitentan OPSUMIT | Actelion |
| June 27, 2008 | NDA022260 | Epoprostenol VELETRI | Actelion |
| July 31, 2003 | NDA021348 | Miglustat ZAVESCA | Actelion |
| November 20, 2001 | NDA021290 | Bosentan TRACLEER | Actelion |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026