FDA.reportPublic FDA data

nitisinone 10 MG Oral Tablet

RxCUI
1941464
RxNorm name
nitisinone 10 MG Oral Tablet
Display name
nitisinone 10 MG Oral Tablet
Full name
nitisinone 10 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITYRNITISINONECycle Pharmaceuticals Ltd.00fd1905-27e4-420e-8dc5-a69e4ddc15262025-12-22Warnings, Adverse reactionsExact identifier
rxcui: 1941464

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
00fd1905-27e4-420e-8dc5-a69e4ddc1526nitisinone 10 MG Oral Tablet [PSN] · nitisinone 10 MG Oral Tablet [SCD]213These highlights do not include all the information needed to use NITYR safely and effectively. See full prescribing information for NITYR. NITYR ® (nitisinone) tablets, for oral use Initial U.S. Approval: 200220251222