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United States · US · US:57894-800_d235e5b0-4de6-4235-92ef-ed05fa5892b2

IMAAVY

UNIISPLATC L04AL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerJanssen Biotech, Inc.
CountryUS (United States)
ATC codeL04AL
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5789480001
    1 VIAL, SINGLE-DOSE in 1 BOX (57894-800-01) / 1.62 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
87M90CV8NC
NIPOCALIMAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "87M90CV8NC",
    "rxcui": null,
    "inchikey": null,
    "display_name": "NIPOCALIMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "8886274c-f2b2-48af-85c1-2f90bfe304b8": {
      "match": "brand_token",
      "title": "IMAAVY (NIPOCALIMAB-AAHU) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.]",
      "spl_version": "4",
      "published_date": "2026-05-28"
    }
  },
  "productid": "57894-800_d235e5b0-4de6-4235-92ef-ed05fa5892b2",
  "productndc": "57894-800",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIPOCALIMAB",
  "proprietary_name": "IMAAVY",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761430",
  "marketing_category": "BLA",
  "nonproprietary_name": "nipocalimab-aahu",
  "start_marketing_date": "20250429",
  "active_numerator_strength": "185"
}

Related drugs

Other records sharing ATC code L04AL.

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