<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61434-019-02
</NDCCode>
<PackageDescription>
560 VIAL in 1 CASE (61434-019-02) / 2.25 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
61434-0019-02
</NDC11Code>
<ProductNDC>
61434-019
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lanadelumab-flyo
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20180824
</StartMarketingDate>
<EndMarketingDate>
20260331
</EndMarketingDate>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Catalent Indiana, LLC
</LabelerName>
<SubstanceName>
LANADELUMAB
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/2.25mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-12-31
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
24-AUG-18
</StartMarketingDatePackage>
<EndMarketingDatePackage>
31-MAR-26
</EndMarketingDatePackage>
<SamplePackage/>
</NDC>