<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0003-6120-01
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (0003-6120-01) / 5 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
00003-6120-01
</NDC11Code>
<ProductNDC>
0003-6120
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Opdivo Qvantig
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Nivolumab And Hyaluronidase-nvhy
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20250102
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761381
</ApplicationNumber>
<LabelerName>
E.R. Squibb & Sons, L.L.C.
</LabelerName>
<SubstanceName>
HYALURONIDASE (HUMAN RECOMBINANT); NIVOLUMAB
</SubstanceName>
<StrengthNumber>
2000; 120
</StrengthNumber>
<StrengthUnit>
U/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-14
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250102
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>