OMALIZUMAB - Food and Drug Administration

Manufacturer: Food and Drug Administration
Effective date: 2019-01-03
Label type: Indexing - product concept
Version: 1
Source: full-release
Hydrated at: 2026-06-05 00:18:01

Label at a glance#

ProductOMALIZUMAB

Active ingredientOMALIZUMAB

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

OMALIZUMAB

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OMALIZUMAB	2P471X1Z11	ACTIB
OMALIZUMAB	2P471X1Z11	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XOLAIR	OMALIZUMAB	Genentech, Inc.	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OMALIZUMAB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.