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 ID: 50242-040_2c703552-8c5b-4c50-b673-507f12080a27
• NDC: 50242-040
• Product Type: Human Prescription Drug
• Proprietary Name: XOLAIR
• Generic Name: Omalizumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2003-06-20
• Marketing Category: BLA / BLA
• Application Number: BLA103976
• Labeler Name: Genentech, Inc.
• Substance Name: OMALIZUMAB
• Active Ingredient Strength: 203 mg/1.4mL
• Pharm Classes: Anti-IgE [EPC],Decreased IgE Activity [PE],IgE-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

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 Date: 2003-06-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-040-62 [50242004062]

XOLAIR INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103976
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-06-20

NDC 50242-040-86 [50242004086]

XOLAIR INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103976
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-12-20

Drug Details

Active Ingredients

Ingredient	Strength
OMALIZUMAB	202.5 mg/1.4mL

OpenFDA Data

• SPL SET ID: 7f6a2191-adfb-48b9-9bfa-0d9920479f0d
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • 2P471X1Z11
• 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"

NDC	Brand Name	Generic Name
50242-040	XOLAIR	omalizumab
50242-214	Xolair PFS	omalizumab
50242-215	Xolair PFS	omalizumab