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 |
|---|---|---|---|---|---|---|
| gadobutrol | GADOBUTROL | Zydus Pharmaceuticals USA Inc. | 4ea8ae43-22ca-40c0-be72-c91a321cafd1 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| gadobutrol | GADOBUTROL | Viwit Pharmaceutical Co., Ltd. | 18c67a70-0c1f-46d4-a123-66080090b71b | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Gadobutrol | GADOBUTROL | Fresenius Kabi USA, LLC | c0dd1618-0bb3-4974-846b-e5afc2311ae6 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Gadobutrol | GADOBUTROL | Fresenius Kabi USA, LLC | 007696d0-4b62-4937-9640-4ad619504df4 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| gadobutrol | GADOBUTROL | Slate Run Pharmaceuticals, LLC | 52fbda34-9974-4f9f-9749-6b17d0495b62 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| gadobutrol | GADOBUTROL | Slate Run Pharmaceuticals, LLC | 832e0ae1-4fe1-4dff-9978-c9200bcebb55 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| gadobutrol | GADOBUTROL | Slate Run Pharmaceuticals, LLC | 4af6ee2b-d039-497f-a8f0-bdf948e5f54e | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Gadavist | GADOBUTROL | Bayer HealthCare Pharmaceuticals Inc. | 3c5101a0-0c7e-4078-8dc3-a57beb9a0e92 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Gadavist | GADOBUTROL | Bayer HealthCare Pharmaceuticals Inc. | b7afe34d-b70f-41a5-b89c-561bdf29f046 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Gadavist | GADOBUTROL | Bayer HealthCare Pharmaceuticals Inc. | bd28560f-de4d-4140-874e-31df823f4dbb | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |