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United States · US · US:57894-502_7a931e23-16ed-4112-a593-6c1a696cd4aa
DARZALEX
UNIISPLATC L01FC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Biotech, Inc.
CountryUS (United States)
ATC codeL01FC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1157894502051 VIAL in 1 CARTON (57894-502-05) / 5 mL in 1 VIAL
- ndc1157894502201 VIAL in 1 CARTON (57894-502-20) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
4Z63YK6E0E
DARATUMUMAB
RxCUI 1721947
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4Z63YK6E0E",
"rxcui": "1721947",
"inchikey": null,
"display_name": "DARATUMUMAB",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"4bb241af-4299-4373-8762-2d6709515db0": {
"match": "brand_token",
"title": "DARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)) INJECTION [JANSSEN BIOTECH, INC.]",
"spl_version": "31",
"published_date": "2026-02-16"
}
},
"productid": "57894-502_7a931e23-16ed-4112-a593-6c1a696cd4aa",
"productndc": "57894-502",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DARATUMUMAB",
"proprietary_name": "DARZALEX",
"active_ingred_unit": "mg/5mL",
"application_number": "BLA761036",
"marketing_category": "BLA",
"nonproprietary_name": "Daratumumab",
"start_marketing_date": "20151116",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01FC01.
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