<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61314-228-94
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (61314-228-94) / 1.7 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
61314-0228-94
</NDC11Code>
<ProductNDC>
61314-228
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Wyost
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Denosumab
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20250602
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761362
</ApplicationNumber>
<LabelerName>
Sandoz Inc
</LabelerName>
<SubstanceName>
DENOSUMAB
</SubstanceName>
<StrengthNumber>
120
</StrengthNumber>
<StrengthUnit>
mg/1.7mL
</StrengthUnit>
<Pharm_Classes>
RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-07
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250602
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>