FDA.reportPublic FDA data

0.4 ML ofatumumab 50 MG/ML Pen Injector

RxCUI
2390949
RxNorm name
0.4 ML ofatumumab 50 MG/ML Pen Injector
Display name
0.4 ML ofatumumab 50 MG/ML Pen Injector
Full name
0.4 ML ofatumumab 50 MG/ML Pen Injector
Term type
SCD
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: 2390949

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-b939df133ca3ofatumumab 20 MG in 0.4 ML Pen Injector [PSN] · 0.4 ML ofatumumab 50 MG/ML Pen Injector [SCD] · ofatumumab 20 MG per 0.4 ML Pen Injector [SY]311These 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