NDC 50242-214

Xolair PFS

Omalizumab

Xolair PFS 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 ID50242-214_2c703552-8c5b-4c50-b673-507f12080a27
NDC50242-214
Product TypeHuman Prescription Drug
Proprietary NameXolair PFS
Generic NameOmalizumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-09-28
Marketing CategoryBLA / BLA
Application NumberBLA103976
Labeler NameGenentech, Inc.
Substance NameOMALIZUMAB
Active Ingredient Strength75 mg/.5mL
Pharm ClassesAnti-IgE [EPC],Decreased IgE Activity [PE],IgE-directed Antibody Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50242-214-01

1 SYRINGE, GLASS in 1 CARTON (50242-214-01) > .5 mL in 1 SYRINGE, GLASS
Marketing Start Date2018-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-214-01 [50242021401]

Xolair PFS INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103976
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-28

NDC 50242-214-86 [50242021486]

Xolair PFS INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103976
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-28

Drug Details

Active Ingredients

IngredientStrength
OMALIZUMAB75 mg/.5mL

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 PFS" or generic name "Omalizumab"

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