<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
55370-790-00
</NDCCode>
<PackageDescription>
16800 TABLET, EXTENDED RELEASE in 1 DRUM (55370-790-00)
</PackageDescription>
<NDC11Code>
55370-0790-00
</NDC11Code>
<ProductNDC>
55370-790
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Loratadine And Pseudoephedrine Sulfate
</NonProprietaryName>
<DosageFormName>
TABLET, EXTENDED RELEASE
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20091201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Patheon Puerto Rico, Inc.
</LabelerName>
<SubstanceName>
LORATADINE; PSEUDOEPHEDRINE SULFATE
</SubstanceName>
<StrengthNumber>
10; 240
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2024-02-24
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
01-DEC-09
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>