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United States · US · US:72493-103_e545c060-c1c8-43af-b77e-7e951af59e1d
JELMYTO
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
- ndc1172493103031 KIT in 1 CARTON (72493-103-03) * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-101-40) * 20 mL in 1 VIAL, SINGLE-DOSE (72493-102-20)
Annotations
Orange Book
N211728
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"3d3d5053-5427-4a68-a40b-edb60699521e": {
"match": "brand_token",
"title": "JELMYTO (MITOMYCIN) KIT [UROGEN PHARMA, INC.]",
"spl_version": "6",
"published_date": "2025-07-21"
}
},
"productid": "72493-103_e545c060-c1c8-43af-b77e-7e951af59e1d",
"productndc": "72493-103",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "211728",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG/VIAL",
"product_no": "001",
"approval_date": "Apr 15, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "JELMYTO",
"active_ingred_unit": null,
"application_number": "NDA211728",
"marketing_category": "NDA",
"nonproprietary_name": "mitomycin",
"start_marketing_date": "20200501",
"active_numerator_strength": null
}Access this data programmatically
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