<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61958-3701-1
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (61958-3701-1) * 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3601-3) * 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-4)
</PackageDescription>
<NDC11Code>
61958-3701-01
</NDC11Code>
<ProductNDC>
61958-3701
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Bixlenvo Sunlenca Starter Pack
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Bictegravir/lenacapavir, Lenacapavir Sodium
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20261031
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA221443
</ApplicationNumber>
<LabelerName>
Gilead Sciences, Inc.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-11-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20261031
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>