<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42858-562-42
</NDCCode>
<PackageDescription>
1 KIT in 1 BOX (42858-562-42) * 11 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42858-564-19) * 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42858-563-32)
</PackageDescription>
<NDC11Code>
42858-0562-42
</NDC11Code>
<ProductNDC>
42858-562
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Varenicline
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Varenicline
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20250521
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA213268
</ApplicationNumber>
<LabelerName>
Rhodes Pharmaceuticals L.P.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2026-01-23
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250521
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>