<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72493-106-03
</NDCCode>
<PackageDescription>
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)
</PackageDescription>
<NDC11Code>
72493-0106-03
</NDC11Code>
<ProductNDC>
72493-106
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Zusduri
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Mitomycin
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20250701
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA215793
</ApplicationNumber>
<LabelerName>
UroGen Pharma, Inc
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250701
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>