<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43624-013-01
</NDCCode>
<PackageDescription>
6 TRAY in 1 BOX (43624-013-01) / 120 VIAL, SINGLE-DOSE in 1 TRAY / 5 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
43624-0013-01
</NDC11Code>
<ProductNDC>
43624-013
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Vestronidase Alfa-vjbk
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20171115
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
BSP Pharmaceuticals S.p.A.
</LabelerName>
<SubstanceName>
VESTRONIDASE ALFA-VJBK
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-02-25
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
15-NOV-17
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>