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#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
7cf67e24-d46b-4376-bbd0-0b973c406d0dHARLIKU 2 MG Oral TabletPSN1These 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
7cf67e24-d46b-4376-bbd0-0b973c406d0dnitisinone 2 MG Oral Tablet [Harliku]SBD1These 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
7cf67e24-d46b-4376-bbd0-0b973c406d0dHarliku 2 MG Oral TabletSY1These 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