FDA.reportPublic FDA data

0.4 ML Kesimpta 50 MG/ML Pen Injector

RxCUI
2390954
RxNorm name
0.4 ML Kesimpta 50 MG/ML Pen Injector
Display name
0.4 ML Kesimpta 50 MG/ML Pen Injector
Full name
0.4 ML Kesimpta 50 MG/ML Pen Injector
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:02

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125326Arzerraofatumumab351(a)Disc2026-08-01

RxNav Current And Historical NDCs#

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

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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
KESIMPTAOFATUMUMABNovartis Pharmaceuticals Corporation6a8a3f53-2062-48ff-9dbe-b939df133ca32026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 2390954

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
6a8a3f53-2062-48ff-9dbe-b939df133ca3KESIMPTA 20 MG in 0.4 ML Pen Injector [PSN] · 0.4 ML ofatumumab 50 MG/ML Pen Injector [Kesimpta] [SBD] · 0.4 ML Kesimpta 50 MG/ML Pen Injector [SY] · KESIMPTA 20 MG per 0.4 ML Sensoready Pen Injector [SY]411These highlights do not include all the information needed to use KESIMPTA safely and effectively. See full prescribing information for KESIMPTA. KESIMPTA ® (ofatumumab) injection, for subcutaneous use Initial U.S. Approval: 200920260401