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United States · US · US:72493-106_5437ba4d-fe9b-4dde-b9b9-97a1389fd682

ZUSDURI

Orange BookSPL

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

Identification

ManufacturerUroGen Pharma, Inc
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7249310603
    1 KIT in 1 CARTON (72493-106-03) * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-104-40) * 60 mL in 1 VIAL, SINGLE-DOSE (72493-105-60)

Annotations

Orange Book
N215793
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "8dc68793-bca8-4e3d-b672-622961b58255": {
      "match": "brand_token",
      "title": "ZUSDURI (MITOMYCIN) KIT [UROGEN PHARMA, INC]",
      "spl_version": "2",
      "published_date": "2025-07-02"
    }
  },
  "productid": "72493-106_5437ba4d-fe9b-4dde-b9b9-97a1389fd682",
  "productndc": "72493-106",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215793",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 12, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ZUSDURI",
  "active_ingred_unit": null,
  "application_number": "NDA215793",
  "marketing_category": "NDA",
  "nonproprietary_name": "Mitomycin",
  "start_marketing_date": "20250701",
  "active_numerator_strength": null
}

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