FDA.reportPublic FDA data

omalizumab 75 MG in 0.5 ML Prefilled Syringe

RxCUI
2058949
RxNorm name
omalizumab 75 MG in 0.5 ML Prefilled Syringe
Display name
omalizumab 75 MG in 0.5 ML Prefilled Syringe
Full name
omalizumab 75 MG in 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103976Xolairomalizumab351(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
XOLAIROMALIZUMABGenentech, Inc.7f6a2191-adfb-48b9-9bfa-0d9920479f0d2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2058949

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
7f6a2191-adfb-48b9-9bfa-0d9920479f0domalizumab 75 MG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML omalizumab 150 MG/ML Prefilled Syringe [SCD] · omalizumab 75 MG per 0.5 ML Prefilled Syringe [SY]331These highlights do not include all the information needed to use XOLAIR safely and effectively. See full prescribing information for XOLAIR. XOLAIR ® (omalizumab) injection, for subcutaneous use XOLAIR ® (omalizumab) for injection, for subcutaneous use Initial U.S. Approval: 200320251202