FDA.reportPublic FDA data

ruxolitinib 15 MG (as ruxolitinib phosphate 19.8 MG) per 1 GM Topical Cream

RxCUI
2570752
RxNorm name
ruxolitinib 15 MG (as ruxolitinib phosphate 19.8 MG) per 1 GM Topical Cream
Display name
ruxolitinib 15 MG (as ruxolitinib phosphate 19.8 MG) per 1 GM Topical Cream
Full name
ruxolitinib 15 MG (as ruxolitinib phosphate 19.8 MG) per 1 GM Topical Cream
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

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.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OPZELURARUXOLITINIBIncyte Corporation24da5509-6631-4795-9d42-273faecd08e72026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2570752

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
24da5509-6631-4795-9d42-273faecd08e7ruxolitinib 15 MG/ML Topical Cream [PSN] · ruxolitinib 15 MG/ML Topical Cream [SCD] · ruxolitinib 1.5 % Topical Cream [SY] · ruxolitinib 15 MG (as ruxolitinib phosphate 19.8 MG) per 1 GM Topical Cream [SY]413These highlights do not include all the information needed to use OPZELURA cream safely and effectively. See full prescribing information for OPZELURA cream. OPZELURA ® (ruxolitinib) cream, for topical use Initial U.S. Approval: 201120251111