FDA.reportPublic FDA data

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
IngredientStrength
OMALIZUMAB150 mg/1.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P471X1Z11
Rxcui1657209, 1657212, 2058943, 2058946, 2058949, 2058950, 2663917, 2663918, 2663920, 2663923, 2673760, 2673761, 2673762, 2673763

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ecba0c95-af31-4e39-991d-3814ccdaeba6Product name120190103
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-040-62XOLAIR1.2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1.231
50242-040-62XOLAIR1 in 1 CARTONINJECTION, SOLUTION131
50242-040-86XOLAIR1 in 1 CARTONINJECTION, SOLUTION131
50242-040-86XOLAIR1.2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1.231

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-040-62EA - Each50242-04025962e90-d014-4788-8bec-fef7f17ad70612012-07-24
50242-040-86EA - Each50242-04071b55c53-8382-46b6-ac89-d36861b211e312020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMALIZUMABACTIVE INGREDIENT2P471X1Z11XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]5
OMALIZUMABACTIVE MOIETY2P471X1Z11XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]5
HISTIDINEINACTIVE INGREDIENT4QD397987EXOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]5
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEINACTIVE INGREDIENTX573657P6PXOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]5
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHXOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-040XOLAIR (OMALIZUMAB) INJECTION, SOLUTION XOLAIR PFS (OMALIZUMAB) INJECTION, SOLUTION XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]28Current NDC, Legacy NDC, 4 package rows20241123_7f6a2191-adfb-48b9-9bfa-0d9920479f0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2673760omalizumab 150 MG in 1 ML Auto-InjectorPSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2058943omalizumab 150 MG in 1 ML Prefilled SyringePSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
1657209omalizumab 150 MG InjectionPSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2663920omalizumab 300 MG in 2 ML Auto-InjectorPSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2663917omalizumab 300 MG in 2 ML Prefilled SyringePSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2673762omalizumab 75 MG in 0.5 ML Auto-InjectorPSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2058949omalizumab 75 MG in 0.5 ML Prefilled SyringePSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2673761Xolair 150 MG in 1 ML Auto-InjectorPSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2058946Xolair 150 MG in 1 ML Prefilled SyringePSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
1657212Xolair 150 MG InjectionPSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2663923Xolair 300 MG in 2 ML Auto-InjectorPSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2663918Xolair 300 MG in 2 ML Prefilled SyringePSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2673763Xolair 75 MG in 0.5 ML Auto-InjectorPSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2058950Xolair 75 MG in 0.5 ML Prefilled SyringePSN7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
26737630.5 ML omalizumab 150 MG/ML Auto-Injector [Xolair]SBD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
20589500.5 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]SBD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
26737611 ML omalizumab 150 MG/ML Auto-Injector [Xolair]SBD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
20589461 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]SBD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
26639232 ML omalizumab 150 MG/ML Auto-Injector [Xolair]SBD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
26639182 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]SBD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
1657212omalizumab 150 MG Injection [Xolair]SBD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
26737620.5 ML omalizumab 150 MG/ML Auto-InjectorSCD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
20589490.5 ML omalizumab 150 MG/ML Prefilled SyringeSCD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
26737601 ML omalizumab 150 MG/ML Auto-InjectorSCD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
20589431 ML omalizumab 150 MG/ML Prefilled SyringeSCD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
26639202 ML omalizumab 150 MG/ML Auto-InjectorSCD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
26639172 ML omalizumab 150 MG/ML Prefilled SyringeSCD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
1657209omalizumab 150 MG InjectionSCD7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
20589500.5 ML Xolair 150 MG/ML Prefilled SyringeSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
20589461 ML Xolair 150 MG/ML Prefilled SyringeSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2673760omalizumab 150 MG per 1 ML Auto-InjectorSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2058943omalizumab 150 MG per 1 ML Prefilled SyringeSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2663920omalizumab 300 MG per 2 ML Auto-InjectorSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2663917omalizumab 300 MG per 2 ML Prefilled SyringeSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2673762omalizumab 75 MG per 0.5 ML Auto-InjectorSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2058949omalizumab 75 MG per 0.5 ML Prefilled SyringeSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
1657212Xolair 150 MG InjectionSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2673761Xolair 150 MG per 1 ML Auto-InjectorSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2058946Xolair 150 MG per 1 ML Prefilled SyringeSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2663923Xolair 300 MG per 2 ML Auto-InjectorSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2663918Xolair 300 MG per 2 ML Prefilled SyringeSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2673763Xolair 75 MG per 0.5 ML Auto-InjectorSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31
2058950Xolair 75 MG per 0.5 ML Prefilled SyringeSY7f6a2191-adfb-48b9-9bfa-0d9920479f0d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-040-62502420040621 VIAL, SINGLE-USE in 1 CARTON (50242-040-62) / 1.2 mL in 1 VIAL, SINGLE-USE2003-06-200000-00-00NoNoCurrent
50242-040-86502420040861 VIAL, SINGLE-USE in 1 CARTON (50242-040-86) / 1.2 mL in 1 VIAL, SINGLE-USE2013-12-200000-00-00YesNoCurrent