<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
53360-4142-6
</NDCCode>
<PackageDescription>
50 BLISTER PACK in 1 BOX (53360-4142-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
53360-4142-06
</NDC11Code>
<ProductNDC>
53360-4142
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dronedarone
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20090701
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Sanofi Winthrop Industrie
</LabelerName>
<SubstanceName>
DRONEDARONE
</SubstanceName>
<StrengthNumber>
400
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2023-01-24
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20241231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
01-JUL-09
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>