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United States · US · US:50242-214_e633fdb6-7fbc-4072-93ed-4e30abc6c3a1

Xolair PFS

UNIISPLATC R03DX05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeR03DX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    5024221401
    1 SYRINGE, GLASS in 1 CARTON (50242-214-01) / .5 mL in 1 SYRINGE, GLASS
  • ndc11
    5024221403
    1 SYRINGE, GLASS in 1 CARTON (50242-214-03) / .5 mL in 1 SYRINGE, GLASS
  • ndc11
    5024221455
    1 SYRINGE, GLASS in 1 CARTON (50242-214-55) / .5 mL in 1 SYRINGE, GLASS
  • ndc11
    5024221483
    1 SYRINGE, GLASS in 1 CARTON (50242-214-83) / .5 mL in 1 SYRINGE, GLASS
  • ndc11
    5024221486
    1 SYRINGE, GLASS in 1 CARTON (50242-214-86) / .5 mL in 1 SYRINGE, GLASS
  • ndc11
    5024221499
    1 SYRINGE, GLASS in 1 CARTON (50242-214-99) / .5 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)
2P471X1Z11
OMALIZUMAB
RxCUI 302379
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2P471X1Z11",
    "rxcui": "302379",
    "inchikey": null,
    "display_name": "OMALIZUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "7f6a2191-adfb-48b9-9bfa-0d9920479f0d": {
      "match": "brand_token",
      "title": "XOLAIR (OMALIZUMAB) INJECTION, SOLUTION XOLAIR PFS (OMALIZUMAB) INJECTION, SOLUTION XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]",
      "spl_version": "31",
      "published_date": "2025-12-10"
    }
  },
  "productid": "50242-214_e633fdb6-7fbc-4072-93ed-4e30abc6c3a1",
  "productndc": "50242-214",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMALIZUMAB",
  "proprietary_name": "Xolair PFS",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "BLA103976",
  "marketing_category": "BLA",
  "nonproprietary_name": "omalizumab",
  "start_marketing_date": "20180928",
  "active_numerator_strength": "75"
}

Related drugs

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