xolair pfs

Generic: omalizumab

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name xolair pfs
Generic Name omalizumab
Labeler genentech, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

omalizumab 75 mg/.5mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-214
Product ID 50242-214_e633fdb6-7fbc-4072-93ed-4e30abc6c3a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103976
Listing Expiration 2026-12-31
Marketing Start 2018-09-28

Pharmacologic Class

Established (EPC)
anti-ige [epc]
Mechanism of Action
ige-directed antibody interactions [moa]
Physiologic Effect
decreased ige activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242214
Hyphenated Format 50242-214

Supplemental Identifiers

RxCUI
1657209 1657212 2058943 2058946 2058949 2058950 2663917 2663918 2663920 2663923 2673760 2673761 2673762 2673763
UNII
2P471X1Z11
NUI
N0000175794 N0000175793 N0000175792

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xolair pfs (source: ndc)
Generic Name omalizumab (source: ndc)
Application Number BLA103976 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 75 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (50242-214-01) / .5 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (50242-214-03) / .5 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (50242-214-55) / .5 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (50242-214-83) / .5 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (50242-214-86) / .5 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (50242-214-99) / .5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (6)

50242-214-01 1 SYRINGE, GLASS in 1 CARTON (50242-214-01) / .5 mL in 1 SYRINGE, GLASS 50242-214-03 1 SYRINGE, GLASS in 1 CARTON (50242-214-03) / .5 mL in 1 SYRINGE, GLASS 50242-214-55 1 SYRINGE, GLASS in 1 CARTON (50242-214-55) / .5 mL in 1 SYRINGE, GLASS 50242-214-83 1 SYRINGE, GLASS in 1 CARTON (50242-214-83) / .5 mL in 1 SYRINGE, GLASS 50242-214-86 1 SYRINGE, GLASS in 1 CARTON (50242-214-86) / .5 mL in 1 SYRINGE, GLASS 50242-214-99 1 SYRINGE, GLASS in 1 CARTON (50242-214-99) / .5 mL in 1 SYRINGE, GLASS

Ingredients (1)

omalizumab (75 mg/.5mL)

Linked Drug Pages (1)

XOLAIR, Xolair PFS, Xolair ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "e633fdb6-7fbc-4072-93ed-4e30abc6c3a1", "openfda": {"nui": ["N0000175794", "N0000175793", "N0000175792"], "unii": ["2P471X1Z11"], "rxcui": ["1657209", "1657212", "2058943", "2058946", "2058949", "2058950", "2663917", "2663918", "2663920", "2663923", "2673760", "2673761", "2673762", "2673763"], "spl_set_id": ["7f6a2191-adfb-48b9-9bfa-0d9920479f0d"], "pharm_class_pe": ["Decreased IgE Activity [PE]"], "pharm_class_epc": ["Anti-IgE [EPC]"], "pharm_class_moa": ["IgE-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (50242-214-01)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "50242-214-01", "marketing_start_date": "20180928"}, {"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (50242-214-03)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "50242-214-03", "marketing_start_date": "20230818"}, {"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (50242-214-55)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "50242-214-55", "marketing_start_date": "20230818"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (50242-214-83)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "50242-214-83", "marketing_start_date": "20230818"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (50242-214-86)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "50242-214-86", "marketing_start_date": "20180928"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (50242-214-99)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "50242-214-99", "marketing_start_date": "20230818"}], "brand_name": "Xolair PFS", "product_id": "50242-214_e633fdb6-7fbc-4072-93ed-4e30abc6c3a1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-IgE [EPC]", "Decreased IgE Activity [PE]", "IgE-directed Antibody Interactions [MoA]"], "product_ndc": "50242-214", "generic_name": "omalizumab", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xolair PFS", "active_ingredients": [{"name": "OMALIZUMAB", "strength": "75 mg/.5mL"}], "application_number": "BLA103976", "marketing_category": "BLA", "marketing_start_date": "20180928", "listing_expiration_date": "20261231"}