<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65219-828-05
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (65219-828-05) / 26 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
65219-0828-05
</NDC11Code>
<ProductNDC>
65219-828
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Otulfi
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ustekinumab-aauz
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20240222
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761379
</ApplicationNumber>
<LabelerName>
Fresenius Kabi USA, LLC
</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>
2025-12-29
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240222
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>