<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43598-023-53
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (43598-023-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
43598-0023-53
</NDC11Code>
<ProductNDC>
43598-023
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Varenicline Tartrate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Varenicline Tartrate
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20241213
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA215931
</ApplicationNumber>
<LabelerName>
Dr. Reddys Laboratories Inc.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-29
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241213
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>