<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
64538-282-02
</NDCCode>
<PackageDescription>
1 mg in 1 VIAL, GLASS (64538-282-02)
</PackageDescription>
<NDC11Code>
64538-0282-02
</NDC11Code>
<ProductNDC>
64538-282
</ProductNDC>
<ProductTypeName>
BULK INGREDIENT
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pivekimab Sunirine-pvzy
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20260527
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Rentschler Biopharma SE
</LabelerName>
<SubstanceName>
PIVEKIMAB SUNIRINE
</SubstanceName>
<StrengthNumber>
2
</StrengthNumber>
<StrengthUnit>
mg/2mg
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-06-30
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
27-MAY-26
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>