FDA.reportPublic FDA data

Columvi 10 MG in 10 ML Injection

RxCUI
2639792
RxNorm name
Columvi 10 MG in 10 ML Injection
Display name
Columvi 10 MG in 10 ML Injection
Full name
Columvi 10 MG in 10 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761309Columviglofitamab-gxbm351(a)Rx2026-08-01

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
ColumviGLOFITAMABGenentech, Inc.3516e753-f064-4d30-9bd5-e3f2e143f75d2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2639792

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
3516e753-f064-4d30-9bd5-e3f2e143f75dColumvi 10 MG in 10 ML Injection [PSN] · 10 ML glofitamab-gxbm 1 MG/ML Injection [Columvi] [SBD] · 10 ML Columvi 1 MG/ML Injection [SY] · Columvi 10 MG per 10 ML Injection [SY]47These highlights do not include all the information needed to use COLUMVI ® safely and effectively. See full prescribing information for COLUMVI. COLUMVI (glofitamab-gxbm) injection, for intravenous use Initial U.S. Approval: 202320251103