FDA.reportPublic FDA data

2 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]

RxCUI
2663918
RxNorm name
2 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]
Display name
2 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]
Full name
2 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]
Term type
SBD
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)Rx2026-06-01

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#

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: 2663918

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
7f6a2191-adfb-48b9-9bfa-0d9920479f0d2 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]SBD31These 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
7f6a2191-adfb-48b9-9bfa-0d9920479f0dXolair 300 MG per 2 ML Prefilled SyringeSY31These 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
7f6a2191-adfb-48b9-9bfa-0d9920479f0dXolair 300 MG in 2 ML Prefilled SyringePSN31These 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