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Brand-name prescription medicine

Tracleer

Generic name: Bosentan

FDA application holder: Actelion

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

3Strengths and forms
7Same medicine, other names
2001FDA approval
0Recalls (FDA reports)

Quick answers

What is Tracleer?
Tracleer is a brand name of Bosentan, a prescription medicine. The FDA NDC Directory lists 3 Tracleer products in 3 strengths and forms.
Who makes Tracleer?
Actelion holds the FDA application for Tracleer (NDA021290, approved November 20, 2001).
Is there a generic or store brand of Tracleer?
Yes. The FDA NDC Directory lists 7 other products with the same active ingredients, strength and form as a Tracleer product, 7 of them generic. Ask your pharmacist whether one is right for you.
Has Tracleer been recalled?
No recall linked to Tracleer products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Tracleer is

Each Tracleer 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.

Bosentan · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
bosentan 125 mg
tablet, film coated (oral)		 Tracleer 2 products, 2 companies DailyMed
bosentan 32 mg
tablet, for suspension (oral)		 Tracleer 3 products, 3 companies DailyMed
bosentan 62.5 mg
tablet, film coated (oral)		 Tracleer 2 products, 2 companies DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Bosentan →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Tracleer products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA021290ActelionNovember 20, 20012
NDA209279ActelionSeptember 5, 20171

Companies that list Tracleer

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tracleer products.

Recalls

No recall linked to Tracleer products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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.

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