NDC 66215-232
Tracleer 32 mg tablet, for suspension
On the label: Actelion Pharmaceuticals US, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| HAS Healthcare Advanced Synthesis SA | Biasca, Switzerland | Makes the active ingredient and tests it | No problems foundFeb 20, 2025 · 4 inspections |
| Patheon Inc. | Mississauga, Canada | Makes it | Problems found, fixed voluntarilyFeb 24, 2023 · 7 inspections |
| Allpack Group AG | Reinach, Switzerland | Packages it and labels it | Problems found, fixed voluntarilyApr 28, 2023 · 6 inspections |
| Jetpharma SA | Balerna, Switzerland | Mills it | No problems foundJun 23, 2023 · 6 inspections |
Product details
- Generic drug
- Bosentan: every company that makes it
- Form
- tablet, for suspension, oral
- Strength
- 32 mg
- Approval
- NDA NDA209279
- On the market since
- Jul 29, 2021
- Package NDCs
66215-232-1466215-232-56- Official label
- DailyMed (National Library of Medicine), updated Nov 17, 2025
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