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 |
|---|---|---|---|---|---|---|
| Nitisinone | NITISINONE | Par Health USA, LLC | 437868f5-1c9e-4b0f-8a03-77df8ac0900d | 2026-08-06 | Warnings, Adverse reactions | Name/manufacturer search |
| Nitisinone | NITISINONE | Analog Pharma | 645c8387-30d5-4a86-a5d8-2f6b5df6d5f0 | 2025-09-05 | Warnings, Adverse reactions | Name/manufacturer search |
| Nitisinone | NITISINONE | Eton Pharmaceuticals, Inc. | dc5e4875-fcd7-408c-88c9-4a715f4384b6 | 2024-02-02 | Warnings, Adverse reactions | Name/manufacturer search |
| Nitisinone | NITISINONE | Bryant Ranch Prepack | c1b3adc8-02fa-4e22-8c05-8f32b586e53f | 2024-01-10 | Warnings, Adverse reactions | Name/manufacturer search |
| Nitisinone | NITISINONE | Bryant Ranch Prepack | 8cec0318-9f55-4340-b14b-588635619251 | 2024-01-10 | Warnings, Adverse reactions | Name/manufacturer search |
| Nitisinone | NITISINONE | Bryant Ranch Prepack | b7c38003-6899-4508-a69a-aef1231de22c | 2024-01-10 | Warnings, Adverse reactions | Name/manufacturer search |
| NITYR | NITISINONE | Cycle Pharmaceuticals Ltd. | 00fd1905-27e4-420e-8dc5-a69e4ddc1526 | 2025-12-22 | Warnings, Adverse reactions | Name/manufacturer search |
| ORFADIN | NITISINONE | Swedish Orphan Biovitrum AB (publ) | 00307f42-748d-4227-8c6f-ed5f0a89ae0a | 2025-12-18 | Warnings, Adverse reactions | Name/manufacturer search |
| HARLIKU | NITISINONE | Cycle Pharmaceuticals Ltd. | 7cf67e24-d46b-4376-bbd0-0b973c406d0d | 2025-06-02 | Warnings, Adverse reactions | Name/manufacturer search |
| Orfadin | NITISINONE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 5d449b73-d503-4132-b978-d890491975df | 2021-11-30 | Warnings, Adverse reactions | Name/manufacturer search |