Darzalex Faspro

UNIISPLATC L01FC

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

Identification

ManufacturerJanssen Biotech, Inc.

CountryUS (United States)

ATC codeL01FC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5789450301
1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 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": "SUBCUTANEOUS",
  "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": "57894-503_8cd9a8a9-e03e-4557-8b3b-c9d280024acf",
  "productndc": "57894-503",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DARATUMUMAB; HYALURONIDASE (HUMAN RECOMBINANT)",
  "proprietary_name": "Darzalex Faspro",
  "active_ingred_unit": "mg/15mL; U/15mL",
  "application_number": "BLA761145",
  "marketing_category": "BLA",
  "nonproprietary_name": "daratumumab and hyaluronidase-fihj (human recombinant)",
  "start_marketing_date": "20200501",
  "active_numerator_strength": "1800; 30000"
}

Access this data programmatically

Query Darzalex Faspro and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs