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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
- ndc1172493106031 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
}Access this data programmatically
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