<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
50242-554-86
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-USE in 1 CARTON (50242-554-86) / 23 mL in 1 VIAL, SINGLE-USE
</PackageDescription>
<NDC11Code>
50242-0554-86
</NDC11Code>
<ProductNDC>
50242-554
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ocrevus Zunovo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ocrelizumab And Hyaluronidase
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20240913
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761371
</ApplicationNumber>
<LabelerName>
Genentech, Inc.
</LabelerName>
<SubstanceName>
HYALURONIDASE (HUMAN RECOMBINANT); OCRELIZUMAB
</SubstanceName>
<StrengthNumber>
23000; 920
</StrengthNumber>
<StrengthUnit>
U/23mL; mg/23mL
</StrengthUnit>
<Pharm_Classes>
Antibodies, Monoclonal [CS], Antibodies, Monoclonal, Humanized [CS], CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC], Endoglycosidase [EPC], Glycoside Hydrolases [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-18
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240913
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
Y
</SamplePackage>
</NDC>