<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43068-715-03
</NDCCode>
<PackageDescription>
6 CARTON in 1 BLISTER PACK (43068-715-03) / 1 KIT in 1 CARTON
</PackageDescription>
<NDC11Code>
43068-0715-03
</NDC11Code>
<ProductNDC>
43068-715
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Bysanti
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Milsaperidone
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260701
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA220358
</ApplicationNumber>
<LabelerName>
Vanda Pharmaceuticals Inc.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260701
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>