<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58468-5011-1
</NDCCode>
<PackageDescription>
10 mL in 1 VIAL (58468-5011-1)
</PackageDescription>
<NDC11Code>
58468-5011-01
</NDC11Code>
<ProductNDC>
58468-5011
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Avalglucosidase Alfa
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20210806
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Genzyme Corporation
</LabelerName>
<SubstanceName>
AVALGLUCOSIDASE ALFA
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/10mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-01-01
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
06-AUG-21
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>