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)Rx2026-07-01

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
GazyvaOBINUTUZUMABGenentech, Inc.df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442698

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