Active ingredient
Macitentan
14 finished FDA listings contain Macitentan as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- MACITENTAN
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 14
- Strengths listed
- 10 mg/1
- Brand names in FDA listings
- Opsumit
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1442132
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 204410 | ACTELION | 2013-10-18 | 1 |
| ANDA 211224 | ZYDUS LIFESCIENCES | 2021-04-06 | 1 |
| ANDA 211198 | AUROBINDO PHARMA LTD | 2023-04-18 | 1 |
| ANDA 211195 | APOTEX | 2024-01-09 | 1 |
| ANDA 211107 | TORRENT | 2024-08-05 | 1 |
| ANDA 211128 | ALEMBIC | 2025-08-18 | 2 |
| ANDA 211136 | MSN | 2025-08-20 | 1 |
| ANDA 211123 | SUN PHARM | 2025-08-26 | 1 |
| ANDA 211120 | LAURUS | 2025-11-05 | 1 |
| ANDA 211161 | MYLAN | 2025-12-03 | 1 |
| ANDA 211026 | LEPU PHARM | 2025-12-03 | 1 |
| ANDA 211187 | TEVA PHARMS USA INC | 2026-06-08 | 1 |
| ANDA 211000 | AMNEAL | 2026-06-08 | 1 |
Official labeling on DailyMed
- MACITENTAN TABLET, FILM COATED [APOTEX CORP.] · version 6 · 2026-06-15
- MACITENTAN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] · version 4 · 2026-06-11
- MACITENTAN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 7 · 2026-06-11
- MACITENTAN TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 2 · 2026-06-10
- MACITENTAN TABLET [TORRENT PHARMACEUTICALS LIMITED] · version 8 · 2026-06-10
- MACITENTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] · version 1 · 2026-06-08
- MACITENTAN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2026-06-08
- MACITENTAN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 1 · 2026-06-08
- MACITENTAN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] · version 8 · 2026-06-08
- MACITENTAN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] · version 6 · 2026-05-21
- MACITENTAN TABLET, FILM COATED [LAURUS LABS LIMITED] · version 1 · 2026-05-20
- MACITENTAN TABLET, FILM COATED [NOVUGEN PHARMA (USA) LLC] · version 1 · 2026-05-11
Showing the 12 most recent of 14 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.