<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0597-0035-10
</NDCCode>
<PackageDescription>
2 VIAL, GLASS in 1 CARTON (0597-0035-10) / 7.5 mL in 1 VIAL, GLASS
</PackageDescription>
<NDC11Code>
00597-0035-10
</NDC11Code>
<ProductNDC>
0597-0035
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Spevigo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Spesolimab-sbzo
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20220901
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761244
</ApplicationNumber>
<LabelerName>
Boehringer Ingelheim Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
SPESOLIMAB
</SubstanceName>
<StrengthNumber>
60
</StrengthNumber>
<StrengthUnit>
mg/mL
</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>
20220901
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>