<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84685-300-01
</NDCCode>
<PackageDescription>
1 SYRINGE in 1 CARTON (84685-300-01) / 1.2 mL in 1 SYRINGE
</PackageDescription>
<NDC11Code>
84685-0300-01
</NDC11Code>
<ProductNDC>
84685-300
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Lerochol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lerodalcibep-liga
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20251215
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761427
</ApplicationNumber>
<LabelerName>
LIB Therapeutics, Inc.
</LabelerName>
<SubstanceName>
LERODALCIBEP
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/1.2mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-31
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260331
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>