<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
64239-112-10
</NDCCode>
<PackageDescription>
1 BLISTER PACK in 1 CARTON (64239-112-10) / 2 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
64239-0112-10
</NDC11Code>
<ProductNDC>
64239-112
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Esomeprazole
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Esomeprazole
</NonProprietaryName>
<DosageFormName>
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20240412
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA214278
</ApplicationNumber>
<LabelerName>
Dexcel Pharma Technologies Ltd
</LabelerName>
<SubstanceName>
ESOMEPRAZOLE
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-01-21
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240412
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>