XGEVA

UNIISPLATC M05BX04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmgen, Inc

CountryUS (United States)

ATC codeM05BX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5551373001
1 VIAL, SINGLE-USE in 1 CARTON (55513-730-01) / 1.7 mL in 1 VIAL, SINGLE-USE
ndc11
5551373021
1 VIAL, SINGLE-USE in 1 CARTON (55513-730-21) / 1.7 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

4EQZ6YO2HI

DENOSUMAB

RxCUI 993449

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4EQZ6YO2HI",
    "rxcui": "993449",
    "inchikey": null,
    "display_name": "DENOSUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "628f0998-1206-4001-aeee-18133aa9f3bf": {
      "match": "brand_token",
      "title": "XGEVA (DENOSUMAB) INJECTION [AMGEN, INC]",
      "spl_version": "176",
      "published_date": "2025-09-25"
    }
  },
  "productid": "55513-730_a554622d-cdd7-4ab6-b581-a43fb6fbab45",
  "productndc": "55513-730",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DENOSUMAB",
  "proprietary_name": "XGEVA",
  "active_ingred_unit": "mg/1.7mL",
  "application_number": "BLA125320",
  "marketing_category": "BLA",
  "nonproprietary_name": "denosumab",
  "start_marketing_date": "20101118",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code M05BX04.

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