<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85766-117-12
</NDCCode>
<PackageDescription>
10 PACKET in 1 BOX (85766-117-12) / 1 TABLET, FILM COATED in 1 PACKET (85766-117-46)
</PackageDescription>
<NDC11Code>
85766-0117-12
</NDC11Code>
<ProductNDC>
85766-117
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Medique Loradamed
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Loratadine
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20081230
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA076134
</ApplicationNumber>
<LabelerName>
Sportpharm, Inc. dba Sportpharm
</LabelerName>
<SubstanceName>
LORATADINE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251202
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>