FDA.reportPublic FDA data

2.5 ML glofitamab-gxbm 1 MG/ML Injection [Columvi]

RxCUI
2639795
RxNorm name
2.5 ML glofitamab-gxbm 1 MG/ML Injection [Columvi]
Display name
2.5 ML glofitamab-gxbm 1 MG/ML Injection [Columvi]
Full name
2.5 ML glofitamab-gxbm 1 MG/ML Injection [Columvi]
Term type
SBD
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)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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: 2639795

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3516e753-f064-4d30-9bd5-e3f2e143f75d2.5 ML glofitamab-gxbm 1 MG/ML Injection [Columvi]SBD7These 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
3516e753-f064-4d30-9bd5-e3f2e143f75d2.5 ML Columvi 1 MG/ML InjectionSY7These 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
3516e753-f064-4d30-9bd5-e3f2e143f75dColumvi 2.5 MG per 2.5 ML InjectionSY7These 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
3516e753-f064-4d30-9bd5-e3f2e143f75dColumvi 2.5 MG in 2.5 ML InjectionPSN7These 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