<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42507-414-01
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (42507-414-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-414-00)
</PackageDescription>
<NDC11Code>
42507-0414-01
</NDC11Code>
<ProductNDC>
42507-414
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Omeprazole
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Omeprazole
</NonProprietaryName>
<DosageFormName>
TABLET, DELAYED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260128
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA022032
</ApplicationNumber>
<LabelerName>
HyVee Inc
</LabelerName>
<SubstanceName>
OMEPRAZOLE
</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>
2026-02-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260128
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>