<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58602-727-75
</NDCCode>
<PackageDescription>
2 BLISTER PACK in 1 CARTON (58602-727-75) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
58602-0727-75
</NDC11Code>
<ProductNDC>
58602-727
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Loperamide Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Loperamide Hydrochloride
</NonProprietaryName>
<DosageFormName>
CAPSULE, LIQUID FILLED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251229
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA220372
</ApplicationNumber>
<LabelerName>
Aurohealth LLC
</LabelerName>
<SubstanceName>
LOPERAMIDE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
2
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Opioid Agonist [EPC], Opioid Agonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-08
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251229
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>