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United States · US · US:0143-9166_70159c7c-a439-4a9c-82d4-8c6da6c345eb
XTRENBO
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
- ndc1101439166011 VIAL, SINGLE-DOSE in 1 CARTON (0143-9166-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE
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": {
"a48a3a33-6b0e-4cf4-8786-8f662d6ee77b": {
"match": "brand_token",
"title": "XTRENBO (DENOSUMAB-QBDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
"spl_version": "2",
"published_date": "2026-01-08"
}
},
"productid": "0143-9166_70159c7c-a439-4a9c-82d4-8c6da6c345eb",
"productndc": "0143-9166",
"dosage_form": "INJECTION",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DENOSUMAB",
"proprietary_name": "XTRENBO",
"active_ingred_unit": "mg/1.7mL",
"application_number": "BLA761439",
"marketing_category": "BLA",
"nonproprietary_name": "Denosumab-qbde",
"start_marketing_date": "20260108",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code M05BX04.
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