FDA.reportPublic FDA data

HARLIKU 2 MG Oral Tablet

RxCUI
2719722
RxNorm name
HARLIKU 2 MG Oral Tablet
Display name
HARLIKU 2 MG Oral Tablet
Full name
HARLIKU 2 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

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
HARLIKUNITISINONECycle Pharmaceuticals Ltd.7cf67e24-d46b-4376-bbd0-0b973c406d0d2025-06-02Warnings, Adverse reactionsExact identifier
rxcui: 2719722

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
7cf67e24-d46b-4376-bbd0-0b973c406d0dHARLIKU 2 MG Oral Tablet [PSN] · nitisinone 2 MG Oral Tablet [Harliku] [SBD] · Harliku 2 MG Oral Tablet [SY]31These highlights do not include all the information needed to use HARLIKU safely and effectively. See full prescribing information for HARLIKU. HARLIKU TM (nitisinone) tablets, for oral use Initial U.S. Approval: 200220250602