<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
64538-001-00
</NDCCode>
<PackageDescription>
5 mL in 1 VIAL (64538-001-00)
</PackageDescription>
<NDC11Code>
64538-0001-00
</NDC11Code>
<ProductNDC>
64538-001
</ProductNDC>
<ProductTypeName>
BULK INGREDIENT
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Mepsevii
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20171115
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Rentschler Biopharma SE
</LabelerName>
<SubstanceName>
VESTRONIDASE ALFA
</SubstanceName>
<StrengthNumber>
2
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-01-23
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
15-NOV-17
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>