<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0597-7705-72
</NDCCode>
<PackageDescription>
2 SYRINGE in 1 CARTON (0597-7705-72) / 300 mL in 1 SYRINGE (0597-7705-38)
</PackageDescription>
<NDC11Code>
00597-7705-72
</NDC11Code>
<ProductNDC>
0597-7705
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Spevigo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Spesolimab-sbzo
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250528
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761244
</ApplicationNumber>
<LabelerName>
Boehringer Ingelheim Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
SPESOLIMAB
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/2mL
</StrengthUnit>
<Pharm_Classes>
Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250530
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>