XOLAIR

Product NDC: 50242-040
11-digit product format: 502420040
Labeler code: 50242
Product ID: 50242-040_e633fdb6-7fbc-4072-93ed-4e30abc6c3a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omalizumab
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Genentech, Inc.
Application: BLA103976
Marketing category: BLA
Marketing start: 2003-06-20
Substance: OMALIZUMAB
Active strength: 150 mg/1.2mL
Pharmacologic classes: Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: XOLAIR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMALIZUMAB	150 mg/1.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2P471X1Z11	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1657209	Internal RxNorm lookup
1657212	Internal RxNorm lookup
2058943	Internal RxNorm lookup
2058946	Internal RxNorm lookup
2058949	Internal RxNorm lookup
2058950	Internal RxNorm lookup
2663917	Internal RxNorm lookup
2663918	Internal RxNorm lookup
2663920	Internal RxNorm lookup
2663923	Internal RxNorm lookup
2673760	Internal RxNorm lookup
2673761	Internal RxNorm lookup
2673762	Internal RxNorm lookup
2673763	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7f6a2191-adfb-48b9-9bfa-0d9920479f0d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ecba0c95-af31-4e39-991d-3814ccdaeba6	Product name	1	20190103
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50242-040-62	XOLAIR	1.2 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	1.2	31
50242-040-62	XOLAIR	1 in 1 CARTON	INJECTION, SOLUTION	1	31
50242-040-86	XOLAIR	1 in 1 CARTON	INJECTION, SOLUTION	1	31
50242-040-86	XOLAIR	1.2 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	1.2	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50242-040-62	EA - Each	50242-040	25962e90-d014-4788-8bec-fef7f17ad706	1	2012-07-24
50242-040-86	EA - Each	50242-040	71b55c53-8382-46b6-ac89-d36861b211e3	1	2020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMALIZUMAB	ACTIVE INGREDIENT	2P471X1Z11	XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	5
OMALIZUMAB	ACTIVE MOIETY	2P471X1Z11	XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	5
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	5
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE	INACTIVE INGREDIENT	X573657P6P	XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	5
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50242-040	XOLAIR (OMALIZUMAB) INJECTION, SOLUTION XOLAIR PFS (OMALIZUMAB) INJECTION, SOLUTION XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	28	Current NDC, Legacy NDC, 4 package rows	20241123_7f6a2191-adfb-48b9-9bfa-0d9920479f0d.zip

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	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA103976 ndc (product): 50242-040

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103976	Xolair	omalizumab	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2P471X1Z11	OMALIZUMAB	242138-07-4	OMALIZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2673760	omalizumab 150 MG in 1 ML Auto-Injector	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058943	omalizumab 150 MG in 1 ML Prefilled Syringe	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
1657209	omalizumab 150 MG Injection	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663920	omalizumab 300 MG in 2 ML Auto-Injector	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663917	omalizumab 300 MG in 2 ML Prefilled Syringe	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673762	omalizumab 75 MG in 0.5 ML Auto-Injector	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058949	omalizumab 75 MG in 0.5 ML Prefilled Syringe	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673761	Xolair 150 MG in 1 ML Auto-Injector	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058946	Xolair 150 MG in 1 ML Prefilled Syringe	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
1657212	Xolair 150 MG Injection	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663923	Xolair 300 MG in 2 ML Auto-Injector	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663918	Xolair 300 MG in 2 ML Prefilled Syringe	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673763	Xolair 75 MG in 0.5 ML Auto-Injector	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058950	Xolair 75 MG in 0.5 ML Prefilled Syringe	PSN	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673763	0.5 ML omalizumab 150 MG/ML Auto-Injector [Xolair]	SBD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058950	0.5 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]	SBD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673761	1 ML omalizumab 150 MG/ML Auto-Injector [Xolair]	SBD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058946	1 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]	SBD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663923	2 ML omalizumab 150 MG/ML Auto-Injector [Xolair]	SBD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663918	2 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]	SBD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
1657212	omalizumab 150 MG Injection [Xolair]	SBD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673762	0.5 ML omalizumab 150 MG/ML Auto-Injector	SCD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058949	0.5 ML omalizumab 150 MG/ML Prefilled Syringe	SCD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673760	1 ML omalizumab 150 MG/ML Auto-Injector	SCD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058943	1 ML omalizumab 150 MG/ML Prefilled Syringe	SCD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663920	2 ML omalizumab 150 MG/ML Auto-Injector	SCD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663917	2 ML omalizumab 150 MG/ML Prefilled Syringe	SCD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
1657209	omalizumab 150 MG Injection	SCD	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058950	0.5 ML Xolair 150 MG/ML Prefilled Syringe	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058946	1 ML Xolair 150 MG/ML Prefilled Syringe	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673760	omalizumab 150 MG per 1 ML Auto-Injector	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058943	omalizumab 150 MG per 1 ML Prefilled Syringe	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663920	omalizumab 300 MG per 2 ML Auto-Injector	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663917	omalizumab 300 MG per 2 ML Prefilled Syringe	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673762	omalizumab 75 MG per 0.5 ML Auto-Injector	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058949	omalizumab 75 MG per 0.5 ML Prefilled Syringe	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
1657212	Xolair 150 MG Injection	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673761	Xolair 150 MG per 1 ML Auto-Injector	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058946	Xolair 150 MG per 1 ML Prefilled Syringe	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663923	Xolair 300 MG per 2 ML Auto-Injector	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2663918	Xolair 300 MG per 2 ML Prefilled Syringe	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2673763	Xolair 75 MG per 0.5 ML Auto-Injector	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31
2058950	Xolair 75 MG per 0.5 ML Prefilled Syringe	SY	7f6a2191-adfb-48b9-9bfa-0d9920479f0d	31

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50242-040-62	50242004062	1 VIAL, SINGLE-USE in 1 CARTON (50242-040-62) / 1.2 mL in 1 VIAL, SINGLE-USE	2003-06-20	0000-00-00	No	No	Current
50242-040-86	50242004086	1 VIAL, SINGLE-USE in 1 CARTON (50242-040-86) / 1.2 mL in 1 VIAL, SINGLE-USE	2013-12-20	0000-00-00	Yes	No	Current