FDA.reportPublic FDA data

nitisinone 4 MG in 1 mL Oral Suspension

RxCUI
1790310
RxNorm name
nitisinone 4 MG in 1 mL Oral Suspension
Display name
nitisinone 4 MG in 1 mL Oral Suspension
Full name
nitisinone 4 MG in 1 mL Oral Suspension
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

RxNav Current And Historical NDCs#

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UNII Substances#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORFADINNITISINONESwedish Orphan Biovitrum AB (publ)00307f42-748d-4227-8c6f-ed5f0a89ae0a2025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 1790310

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
00307f42-748d-4227-8c6f-ed5f0a89ae0anitisinone 4 MG in 1 mL Oral Suspension [PSN] · nitisinone 4 MG/ML Oral Suspension [SCD] · nitisinone 4 MG per 1 ML Oral Suspension [SY]312These 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: 200220251218