Data / Drug companies / Macitentan
Macitentan: 15 companies and 15 products in the FDA NDC directory
Macitentan is listed in the FDA National Drug Code Directory by 15 companies, with 15 products in commercial distribution. 14 of the products (93.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on October 1, 2026.
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- Companies listing it
- 15
- Products
- 15
- Generic (ANDA) products
- 14 (93.3%)
- Application numbers
- 13
- Routes
- Oral
- Brand names
- Opsumit
- openFDA record search
- api.fda.gov
Companies that list macitentan
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Actelion Pharmaceuticals US, Inc. | 1 | tablet, film coated | New drug applications (NDA) | November 4, 2013 |
| Alembic Pharmaceuticals Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | June 6, 2026 |
| Alembic Pharmaceuticals Limited | 1 | tablet, film coated | Generic drugs (ANDA) | June 6, 2026 |
| Amneal Pharmaceuticals NY LLC | 1 | tablet, film coated | Generic drugs (ANDA) | June 8, 2026 |
| Ani Pharmaceuticals, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | October 1, 2026 |
| Apotex Corp. | 1 | tablet, film coated | Generic drugs (ANDA) | June 11, 2026 |
| Aurobindo Pharma Limited | 1 | tablet, film coated | Generic drugs (ANDA) | June 8, 2026 |
| Laurus Labs Limited | 1 | tablet, film coated | Generic drugs (ANDA) | May 15, 2026 |
| Mylan Pharmaceuticals Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | June 8, 2026 |
| Novugen Pharma (USA) LLC | 1 | tablet, film coated | Generic drugs (ANDA) | May 7, 2026 |
| Sandoz Inc | 1 | tablet, film coated | Generic drugs (ANDA) | August 20, 2025 |
| Sun Pharmaceutical Industries, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | June 6, 2026 |
| Teva Pharmaceuticals, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | June 8, 2026 |
| Torrent Pharmaceuticals Limited | 1 | tablet | Generic drugs (ANDA) | June 1, 2026 |
| Zydus Pharmaceuticals USA Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | November 5, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 14 | 93.3% |
| Tablet | 1 | 6.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 14 | 93.3% |
| New drug applications (NDA) | 1 | 6.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| Endothelin Receptor Antagonist | 15 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.