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United States · US · US:0469-4425_eec900c3-1365-4353-836e-c5e483e43f6a

VYLOY

UNIISPLATC L01FX31

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

Identification

ManufacturerAstellas Pharma US, Inc.
CountryUS (United States)
ATC codeL01FX31
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0469442530
    1 VIAL in 1 BOX (0469-4425-30) / 15 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
TF5MPQ8WGY
ZOLBETUXIMAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TF5MPQ8WGY",
    "rxcui": null,
    "inchikey": null,
    "display_name": "ZOLBETUXIMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e7695a21-abb6-47ac-93f8-0ece5a9c4409": {
      "match": "brand_token",
      "title": "VYLOY (ZOLBETUXIMAB) INJECTION, POWDER, FOR SUSPENSION [ASTELLAS PHARMA US, INC.]",
      "spl_version": "4",
      "published_date": "2025-06-23"
    }
  },
  "productid": "0469-4425_eec900c3-1365-4353-836e-c5e483e43f6a",
  "productndc": "0469-4425",
  "dosage_form": "INJECTION, POWDER, FOR SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZOLBETUXIMAB",
  "proprietary_name": "VYLOY",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761365",
  "marketing_category": "BLA",
  "nonproprietary_name": "ZOLBETUXIMAB",
  "start_marketing_date": "20250424",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code L01FX31.

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