<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0143-9171-01
</NDCCode>
<PackageDescription>
26 mL in 1 VIAL (0143-9171-01)
</PackageDescription>
<NDC11Code>
00143-9171-01
</NDC11Code>
<ProductNDC>
0143-9171
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Starjemza
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ustekinumab-hmny
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20251027
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761419
</ApplicationNumber>
<LabelerName>
Hikma Pharmaceuticals USA Inc.
</LabelerName>
<SubstanceName>
USTEKINUMAB
</SubstanceName>
<StrengthNumber>
130
</StrengthNumber>
<StrengthUnit>
mg/26mL
</StrengthUnit>
<Pharm_Classes>
Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-10-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251027
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>