<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81646-106-05
</NDCCode>
<PackageDescription>
5 mL in 1 CUP, UNIT-DOSE (81646-106-05)
</PackageDescription>
<NDC11Code>
81646-0106-05
</NDC11Code>
<ProductNDC>
81646-106
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Childrens Loratadine Oral
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Loratadine
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20190212
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA075728
</ApplicationNumber>
<LabelerName>
PINNACLE PHARMA LLC
</LabelerName>
<SubstanceName>
LORATADINE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2023-01-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20221231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20190212
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>