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United States · US · US:50633-230_52bb5505-85d0-256a-e063-6294a90a73a8
DANYELZA
UNIISPLATC L01FX21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBTG International Inc.
CountryUS (United States)
ATC codeL01FX21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
9K8GNJ2874
NAXITAMAB
RxCUI 2474039
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9K8GNJ2874",
"rxcui": "2474039",
"inchikey": null,
"display_name": "NAXITAMAB",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"b0f5ee96-369f-4cb9-a783-3bfa70fe8f90": {
"match": "brand_token",
"title": "DANYELZA (NAXITAMAB) INJECTION [BTG INTERNATIONAL INC.]",
"spl_version": "2",
"published_date": "2026-06-01"
}
},
"productid": "50633-230_52bb5505-85d0-256a-e063-6294a90a73a8",
"productndc": "50633-230",
"dosage_form": "INJECTION",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAXITAMAB",
"proprietary_name": "DANYELZA",
"active_ingred_unit": "mg/10mL",
"application_number": "BLA761171",
"marketing_category": "BLA",
"nonproprietary_name": "Naxitamab",
"start_marketing_date": "20201125",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L01FX21.
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