<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81033-067-34
</NDCCode>
<PackageDescription>
30 CUP, UNIT-DOSE in 1 CARTON (81033-067-34) / 7.5 mL in 1 CUP, UNIT-DOSE (81033-067-07)
</PackageDescription>
<NDC11Code>
81033-0067-34
</NDC11Code>
<ProductNDC>
81033-067
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Loperamide Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Loperamide Hydrochloride
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20241113
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA220100
</ApplicationNumber>
<LabelerName>
Kesin Pharma Corporation
</LabelerName>
<SubstanceName>
LOPERAMIDE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/7.5mL
</StrengthUnit>
<Pharm_Classes>
Opioid Agonist [EPC], Opioid Agonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260630
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>