<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72657-131-89
</NDCCode>
<PackageDescription>
1 KIT in 1 PACKAGE (72657-131-89) * 1 BOTTLE in 1 CARTON / 60 TABLET in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 90 TABLET in 1 BOTTLE
</PackageDescription>
<NDC11Code>
72657-0131-89
</NDC11Code>
<ProductNDC>
72657-131
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Cetirizine Hcl
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Cetirizine
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20240513
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA078427
</ApplicationNumber>
<LabelerName>
GLENMARK THERAPEUTICS INC., USA
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-23
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240513
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>