<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0078-1217-61
</NDCCode>
<PackageDescription>
1 VIAL, GLASS in 1 PACKAGE (0078-1217-61) / 7.5 mL in 1 VIAL, GLASS
</PackageDescription>
<NDC11Code>
00078-1217-61
</NDC11Code>
<ProductNDC>
0078-1217
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Pluvicto
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lutetium Lu 177 Vipivotide Tetraxetan
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20220323
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA215833
</ApplicationNumber>
<LabelerName>
Novartis Pharmaceuticals Corporation
</LabelerName>
<SubstanceName>
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
</SubstanceName>
<StrengthNumber>
27
</StrengthNumber>
<StrengthUnit>
mCi/mL
</StrengthUnit>
<Pharm_Classes>
Radioligand Activity [MoA], Radioligand Therapeutic Agent [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260115
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>