Darzalex IV

UNIISPLATC L01FC01

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

Identification

ManufacturerJanssen Biotech, Inc.

CountryUS (United States)

ATC codeL01FC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5789450505
1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-05) / 5 mL in 1 VIAL, SINGLE-DOSE
ndc11
5789450520
1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-20) / 20 mL in 1 VIAL, SINGLE-DOSE

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": "57894-505_7a931e23-16ed-4112-a593-6c1a696cd4aa",
  "productndc": "57894-505",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DARATUMUMAB",
  "proprietary_name": "Darzalex IV",
  "active_ingred_unit": "mg/5mL",
  "application_number": "BLA761036",
  "marketing_category": "BLA",
  "nonproprietary_name": "Daratumumab",
  "start_marketing_date": "20211015",
  "active_numerator_strength": "100"
}

Related drugs

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