<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63552-209-00
</NDCCode>
<PackageDescription>
120 VIAL in 1 TRAY (63552-209-00) / 10 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
63552-0209-00
</NDC11Code>
<ProductNDC>
63552-209
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Naxitamab
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20231107
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Patheon Manufacturing Services LLC
</LabelerName>
<SubstanceName>
NAXITAMAB
</SubstanceName>
<StrengthNumber>
40
</StrengthNumber>
<StrengthUnit>
mg/10mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2024-06-13
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
07-NOV-23
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>