<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
64538-180-00
</NDCCode>
<PackageDescription>
10 mg in 1 VIAL, SINGLE-DOSE (64538-180-00)
</PackageDescription>
<NDC11Code>
64538-0180-00
</NDC11Code>
<ProductNDC>
64538-180
</ProductNDC>
<ProductTypeName>
BULK INGREDIENT
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Velmanase Alfa-tycv
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20230301
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BULK INGREDIENT
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Rentschler Biopharma SE
</LabelerName>
<SubstanceName>
VELMANASE ALFA-TYCV
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/10mg
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-01-23
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
01-MAR-23
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>