<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0469-3425-10
</NDCCode>
<PackageDescription>
1 VIAL in 1 BOX (0469-3425-10) / 5 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
00469-3425-10
</NDC11Code>
<ProductNDC>
0469-3425
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Vyloy
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Zolbetuximab
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, FOR SUSPENSION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20241024
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761365
</ApplicationNumber>
<LabelerName>
Astellas Pharma US, Inc.
</LabelerName>
<SubstanceName>
ZOLBETUXIMAB
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Claudin 18.2-directed Antibody Interactions [MoA], Claudin 18.2-directed Cytolytic Antibody [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-06-21
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241024
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>