nitisinone 20 MG Oral Capsule
- RxCUI
- 1798999
- RxNorm name
- nitisinone 20 MG Oral Capsule
- Display name
- nitisinone 20 MG Oral Capsule
- Full name
- nitisinone 20 MG Oral Capsule
- Term type
- SCD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:00
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nitisinone | NITISINONE | Analog Pharma | 645c8387-30d5-4a86-a5d8-2f6b5df6d5f0 | 2025-09-05 | Warnings, Adverse reactions | 1798999 |
| Nitisinone | NITISINONE | Eton Pharmaceuticals, Inc. | dc5e4875-fcd7-408c-88c9-4a715f4384b6 | 2024-02-02 | Warnings, Adverse reactions | 1798999 |
| Orfadin | NITISINONE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 5d449b73-d503-4132-b978-d890491975df | 2021-11-30 | Warnings, Adverse reactions | 1798999 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 5d449b73-d503-4132-b978-d890491975df | nitisinone 20 MG Oral Capsule [PSN] · nitisinone 20 MG Oral Capsule [SCD] | 2 | 14 | These highlights do not include all the information needed to use ORFADIN safely and effectively. See full prescribing information for ORFADIN. ORFADIN ® (nitisinone) capsules, for oral use ORFADIN ® (nitisinone) oral suspension Initial U.S. Approval: 2002 | 20211130 |
| 645c8387-30d5-4a86-a5d8-2f6b5df6d5f0 | nitisinone 20 MG Oral Capsule [PSN] · nitisinone 20 MG Oral Capsule [SCD] | 2 | 7 | These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use Initial U.S. Approval: 2002 | 20250905 |
| dc5e4875-fcd7-408c-88c9-4a715f4384b6 | nitisinone 20 MG Oral Capsule [PSN] · nitisinone 20 MG Oral Capsule [SCD] | 2 | 5 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE Capsules, for oral use Initial U.S. Approval: 2002 | 20240202 |