FDA.reportPublic FDA data

6 ML ublituximab-xiiy 25 MG/ML Injection [Briumvi]

RxCUI
2626359
RxNorm name
6 ML ublituximab-xiiy 25 MG/ML Injection [Briumvi]
Display name
6 ML ublituximab-xiiy 25 MG/ML Injection [Briumvi]
Full name
6 ML ublituximab-xiiy 25 MG/ML Injection [Briumvi]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761238Briumviublituximab-xiiy351(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
BRIUMVIUBLITUXIMABTG Therapeutics, Inc.3a77cd8c-811b-407c-9140-d0c5c26435c22026-02-19Warnings, Adverse reactionsExact identifier
rxcui: 2626359

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3a77cd8c-811b-407c-9140-d0c5c26435c26 ML ublituximab-xiiy 25 MG/ML Injection [Briumvi]SBD21These highlights do not include all the information needed to use BRIUMVI safely and effectively. See full prescribing information for BRIUMVI. BRIUMVI ® (ublituximab-xiiy) injection, for intravenous use Initial U.S. Approval: 202220260219
3a77cd8c-811b-407c-9140-d0c5c26435c2Briumvi 150 MG per 6 ML InjectionSY21These highlights do not include all the information needed to use BRIUMVI safely and effectively. See full prescribing information for BRIUMVI. BRIUMVI ® (ublituximab-xiiy) injection, for intravenous use Initial U.S. Approval: 202220260219
3a77cd8c-811b-407c-9140-d0c5c26435c26 ML Briumvi 25 MG/ML InjectionSY21These highlights do not include all the information needed to use BRIUMVI safely and effectively. See full prescribing information for BRIUMVI. BRIUMVI ® (ublituximab-xiiy) injection, for intravenous use Initial U.S. Approval: 202220260219
3a77cd8c-811b-407c-9140-d0c5c26435c2Briumvi 150 MG in 6 ML InjectionPSN21These highlights do not include all the information needed to use BRIUMVI safely and effectively. See full prescribing information for BRIUMVI. BRIUMVI ® (ublituximab-xiiy) injection, for intravenous use Initial U.S. Approval: 202220260219