<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
71931-820-99
</NDCCode>
<PackageDescription>
2000 mL in 1 BOTTLE (71931-820-99)
</PackageDescription>
<NDC11Code>
71931-0820-99
</NDC11Code>
<ProductNDC>
71931-820
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Cerliponase Alfa
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20200122
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
BioMarin International Limited
</LabelerName>
<SubstanceName>
CERLIPONASE ALFA
</SubstanceName>
<StrengthNumber>
150
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-12-03
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
22-JAN-20
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>