<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
50419-475-72
</NDCCode>
<PackageDescription>
2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71)
</PackageDescription>
<NDC11Code>
50419-0475-72
</NDC11Code>
<ProductNDC>
50419-475
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Lynkuet
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Elinzanetant
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251024
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA219469
</ApplicationNumber>
<LabelerName>
Bayer HealthCare Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
ELINZANETANT
</SubstanceName>
<StrengthNumber>
60
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251024
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
Y
</SamplePackage>
</NDC>