OSPOMYV

UNIISPLATC M05BX04

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

Identification

ManufacturerCordavis Limited

CountryUS (United States)

ATC codeM05BX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8345701210
1 SYRINGE in 1 CARTON (83457-012-10) / 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": {
    "e1d80a82-de52-4a34-9df3-609e50667ffb": {
      "match": "brand_token",
      "title": "OSPOMYV (DENOSUMAB) INJECTION, SOLUTION [CORDAVIS LIMITED]",
      "spl_version": "6",
      "published_date": "2025-11-17"
    }
  },
  "productid": "83457-012_701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9",
  "productndc": "83457-012",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DENOSUMAB",
  "proprietary_name": "OSPOMYV",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761392",
  "marketing_category": "BLA",
  "nonproprietary_name": "denosumab",
  "start_marketing_date": "20251010",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code M05BX04.

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