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United States · US · US:83257-030_09c9ae75-505b-dcae-8765-3628a32e7828

AUKELSO

UNIISPLATC M05BX04

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

Identification

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

Packs · 1

  • ndc11
    8325703011
    1 VIAL, SINGLE-USE in 1 CARTON (83257-030-11) / 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": {
    "547cb095-f7f5-f933-75ce-5e6abf2ad5bc": {
      "match": "brand_token",
      "title": "AUKELSO (DENOSUMAB-KYQQ) INJECTION [BIOCON BIOLOGICS INC.]",
      "spl_version": "2",
      "published_date": "2026-01-06"
    }
  },
  "productid": "83257-030_09c9ae75-505b-dcae-8765-3628a32e7828",
  "productndc": "83257-030",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DENOSUMAB",
  "proprietary_name": "AUKELSO",
  "active_ingred_unit": "mg/1.7mL",
  "application_number": "BLA761436",
  "marketing_category": "BLA",
  "nonproprietary_name": "Denosumab-kyqq",
  "start_marketing_date": "20260105",
  "active_numerator_strength": "120"
}

Related drugs

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