<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
75834-336-24
</NDCCode>
<PackageDescription>
2 BOX in 1 KIT (75834-336-24) / 1 KIT in 1 BOX * 1 BLISTER PACK in 1 BOX (75834-334-25) / 11 TABLET, FILM COATED in 1 BLISTER PACK * 3 BLISTER PACK in 1 BOX (75834-335-26) / 14 TABLET, FILM COATED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
75834-0336-24
</NDC11Code>
<ProductNDC>
75834-336
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Varenicline
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Varenicline
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20260302
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217115
</ApplicationNumber>
<LabelerName>
Nivagen Pharmaceuticals Inc.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260302
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>