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United States· US:57894-503_8cd9a8a9-e03e-4557-8b3b-c9d280024acf

Darzalex Faspro

A cd38 (clusters of differentiation 38) inhibitors product containing daratumumab and hyaluronidase-fihj (human recombinant), registered in United States by Janssen Biotech, Inc..

ATC L01FCUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDarzalex FasproATCL01FCREGISTER NO.US:57894-503_8cd9a8a9…PACKS LISTED1CHECKEDJune 3, 2026
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The record

At a glance

FDA National Drug Code directory (United States)
Active substance
daratumumab and hyaluronidase-fihj (human recombinant)
Manufacturer
Janssen Biotech, Inc.
Country
United States (US)
ATC code
L01FC
ATC class
CD38 (Clusters of Differentiation 38) inhibitors
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    5789450301
    1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 mL in 1 VIAL, SINGLE-DOSE

Regulatory notes

UNII (FDA substance ID)
4Z63YK6E0E
DARATUMUMAB
RxCUI 1721947
DailyMed SPL labels
1 version tracked

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/4a4644e2-356f-4772-9895-f2279541a05b
GET /v1/drugs/4a4644e2-356f-4772-9895-f2279541a05b?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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"
}
API referenceMCP serverPlans

See everything about daratumumab and hyaluronidase-fihj (human recombinant).

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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