FDA.reportPublic FDA data

inotuzumab ozogamicin 0.9 MG Injection [Besponsa]

RxCUI
1942959
RxNorm name
inotuzumab ozogamicin 0.9 MG Injection [Besponsa]
Display name
inotuzumab ozogamicin 0.9 MG Injection [Besponsa]
Full name
inotuzumab ozogamicin 0.9 MG Injection [Besponsa]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:21

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761040Besponsainotuzumab ozogamicin351(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
BesponsaINOTUZUMAB OZOGAMICINWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.cc7014b1-c775-411d-b374-8113248b40772026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1942959

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
cc7014b1-c775-411d-b374-8113248b4077BESPONSA 0.9 MG Injection [PSN] · inotuzumab ozogamicin 0.9 MG Injection [Besponsa] [SBD] · Besponsa 0.9 MG Injection [SY]38These highlights do not include all the information needed to use BESPONSA™ safely and effectively. See full prescribing information for BESPONSA. BESPONSA (inotuzumab ozogamicin) for injection, for intravenous use Initial U.S. Approval: 201720260206