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United States · US · US:0143-9165_ddf6eb2a-4e1f-4cb4-992a-c93cbb5c0cfb

ENOBY

UNIISPLATC M05BX04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeM05BX04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0143916501
    1 SYRINGE in 1 CARTON (0143-9165-01) / 1 mL in 1 SYRINGE

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": {
    "815d3ba4-27a1-4a06-925a-a87f35442bdb": {
      "match": "brand_token",
      "title": "ENOBY (DENOSUMAB-QBDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "5",
      "published_date": "2026-01-19"
    }
  },
  "productid": "0143-9165_ddf6eb2a-4e1f-4cb4-992a-c93cbb5c0cfb",
  "productndc": "0143-9165",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DENOSUMAB",
  "proprietary_name": "ENOBY",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761439",
  "marketing_category": "BLA",
  "nonproprietary_name": "Denosumab-qbde",
  "start_marketing_date": "20260108",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code M05BX04.

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