<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
47783-646-01
</NDCCode>
<PackageDescription>
1 SYRINGE, GLASS in 1 CARTON (47783-646-01) / 2 mL in 1 SYRINGE, GLASS
</PackageDescription>
<NDC11Code>
47783-0646-01
</NDC11Code>
<ProductNDC>
47783-646
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Takhzyro
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lanadelumab-flyo
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20220208
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761090
</ApplicationNumber>
<LabelerName>
Takeda Pharmaceuticals America, Inc.
</LabelerName>
<SubstanceName>
LANADELUMAB
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/2mL
</StrengthUnit>
<Pharm_Classes>
Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-03-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20220208
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>