FDA.reportPublic FDA data

40 ML obinutuzumab 25 MG/ML Injection [Gazyva]

RxCUI
1442698
RxNorm name
40 ML obinutuzumab 25 MG/ML Injection [Gazyva]
Display name
40 ML obinutuzumab 25 MG/ML Injection [Gazyva]
Full name
40 ML obinutuzumab 25 MG/ML Injection [Gazyva]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125486Gazyvaobinutuzumab351(a)Rx2026-10-01

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
df12ceb2-5b4b-4ab5-a317-2a36bf2a3cdaGazyva 1000 MG in 40 ML Injection [PSN] · 40 ML obinutuzumab 25 MG/ML Injection [Gazyva] [SBD] · Gazyva 1000 MG per 40 ML Injection [SY]322These highlights do not include all the information needed to use GAZYVA safely and effectively. See full prescribing information for GAZYVA. GAZYVA ® (obinutuzumab) injection, for intravenous use Initial U.S. Approval: 201320251219