FDA.reportPublic FDA data

0.5 ML omalizumab-igec 150 MG/ML Prefilled Syringe

RxCUI
2726010
RxNorm name
0.5 ML omalizumab-igec 150 MG/ML Prefilled Syringe
Display name
0.5 ML omalizumab-igec 150 MG/ML Prefilled Syringe
Full name
0.5 ML omalizumab-igec 150 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:11

RxNav Current And Historical NDCs#

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UNII Substances#

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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
OMLYCLOOMALIZUMAB-IGECCELLTRION USA, Inc.dbd8709f-1636-45d9-ba94-5a3bc5f22f842026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2726010

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
a2075490-d8e7-4c23-8b2e-8f2cd5a67948omalizumab-igec 75 MG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML omalizumab-igec 150 MG/ML Prefilled Syringe [SCD] · omalizumab-igec 75 MG per 0.5 ML Prefilled Syringe [SY]34These highlights do not include all the information needed to use OMALIZUMAB-IGEC safely and effectively. See full prescribing information for OMALIZUMAB-IGEC. OMALIZUMAB-IGEC injection, for subcutaneous use Initial U.S. Approval: 2025 Omalizumab-igec is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product and that there are no clinically meaningful differences between the20251205