FDA labels
Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.
Label matches#
| Label | Generic name | Manufacturer | SPL set ID | Effective date | Safety fields | Match |
|---|---|---|---|---|---|---|
| macitentan | MACITENTAN | Apotex Corp. | 226049ba-9c76-0798-6725-ee027a041820 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Macitentan | MACITENTAN | Aurobindo Pharma Limited | 88b9f3b0-3f8f-47e4-bbd7-a2a785ed4ac0 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Macitentan | MACITENTAN | Alembic Pharmaceuticals Limited | 4d9d9a84-6853-4004-b20a-8849b34453a4 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Macitentan | MACITENTAN | Alembic Pharmaceuticals Inc. | 98b3309a-5012-42b5-b773-a38c2f52296c | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| MACITENTAN | MACITENTAN | Zydus Pharmaceuticals USA Inc. | 39ed1c20-99ae-4780-b040-dbebfc90018f | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Macitentan | MACITENTAN | Torrent Pharmaceuticals Limited | fbfae088-44e6-4296-81d1-c2b6eecacc81 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Macitentan | MACITENTAN | Novugen Pharma (USA) LLC | 8cabe7dd-1592-4764-a48a-f086288cae61 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| macitentan | MACITENTAN | Sandoz Inc | 91232484-55b7-47dc-bc30-e63a6b469df6 | 2026-04-06 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Macitentan | MACITENTAN | Laurus Labs Limited | 93f0ab4a-4756-4915-a000-ed65b26cd61c | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Macitentan | MACITENTAN | Mylan Pharmaceuticals Inc. | d88a13e7-cf08-4632-86be-dcd979516296 | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Macitentan | MACITENTAN | Sun Pharmaceutical Industries, Inc. | 8de5c74f-b172-4485-a3f0-95e0172299d8 | 2025-06-25 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| macitentan | MACITENTAN | Teva Pharmaceuticals, Inc. | b196010f-2ba2-4fa7-8e19-a58000a9563d | 2025-06-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Macitentan | MACITENTAN | Amneal Pharmaceuticals NY LLC | e153997b-7b61-4737-97bd-ff8be3c09795 | 2025-05-31 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| OPSUMIT | MACITENTAN | Actelion Pharmaceuticals US, Inc. | 1e484a50-55db-4b85-8c57-6cd1b0353abd | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| OPSYNVI | MACITENTAN AND TADALAFIL | Actelion Pharmaceuticals US, Inc. | 6945b183-18d3-40de-afd1-c88e33cc1a63 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |