NDC 50242-040

XOLAIR

Omalizumab

XOLAIR is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Omalizumab.

Product ID50242-040_2c703552-8c5b-4c50-b673-507f12080a27
NDC50242-040
Product TypeHuman Prescription Drug
Proprietary NameXOLAIR
Generic NameOmalizumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2003-06-20
Marketing CategoryBLA / BLA
Application NumberBLA103976
Labeler NameGenentech, Inc.
Substance NameOMALIZUMAB
Active Ingredient Strength203 mg/1.4mL
Pharm ClassesAnti-IgE [EPC],Decreased IgE Activity [PE],IgE-directed Antibody Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50242-040-62

1 VIAL, SINGLE-USE in 1 CARTON (50242-040-62) > 1.4 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2003-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-040-62 [50242004062]

XOLAIR INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103976
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-06-20

NDC 50242-040-86 [50242004086]

XOLAIR INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103976
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-20

Drug Details

Active Ingredients

IngredientStrength
OMALIZUMAB202.5 mg/1.4mL

OpenFDA Data

SPL SET ID:7f6a2191-adfb-48b9-9bfa-0d9920479f0d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1657212
  • 1657209
  • 2058949
  • 2058950
  • 2058946
  • 2058943
  • Pharmacological Class

    • Anti-IgE [EPC]
    • Decreased IgE Activity [PE]
    • IgE-directed Antibody Interactions [MoA]

    NDC Crossover Matching brand name "XOLAIR" or generic name "Omalizumab"

    NDCBrand NameGeneric Name
    50242-040XOLAIRomalizumab
    50242-214Xolair PFSomalizumab
    50242-215Xolair PFSomalizumab

    Trademark Results [XOLAIR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XOLAIR
    XOLAIR
    90794955 not registered Live/Pending
    Novartis AG
    2021-06-25
    XOLAIR
    XOLAIR
    90794951 not registered Live/Pending
    Novartis AG
    2021-06-25
    XOLAIR
    XOLAIR
    85829727 4918470 Live/Registered
    Novartis AG
    2013-01-23
    XOLAIR
    XOLAIR
    79250398 not registered Live/Pending
    Novartis AG
    2018-10-30
    XOLAIR
    XOLAIR
    79250397 not registered Live/Pending
    Novartis AG
    2018-10-30
    XOLAIR
    XOLAIR
    79143692 4590913 Live/Registered
    NOVARTIS AG
    2014-02-05
    XOLAIR
    XOLAIR
    78296612 3086141 Live/Registered
    NOVARTIS AG
    2003-09-05
    XOLAIR
    XOLAIR
    78269788 2998978 Live/Registered
    NOVARTIS AG
    2003-07-02
    XOLAIR
    XOLAIR
    78109911 2707154 Live/Registered
    Novartis AG
    2002-02-20
    XOLAIR
    XOLAIR
    78073589 2678068 Live/Registered
    Novartis AG
    2001-07-12
    XOLAIR
    XOLAIR
    75388270 not registered Dead/Abandoned
    NOVARTIS AG
    1997-11-12

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