<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
45963-565-00
</NDCCode>
<PackageDescription>
5000 TABLET in 1 BOX (45963-565-00)
</PackageDescription>
<NDC11Code>
45963-0565-00
</NDC11Code>
<ProductNDC>
45963-565
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ezetimibe And Simvastatin
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20170426
</StartMarketingDate>
<EndMarketingDate>
20260228
</EndMarketingDate>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Actavis Pharma, Inc.
</LabelerName>
<SubstanceName>
EZETIMIBE; SIMVASTATIN
</SubstanceName>
<StrengthNumber>
10; 10
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-09-04
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
26-APR-17
</StartMarketingDatePackage>
<EndMarketingDatePackage>
28-FEB-26
</EndMarketingDatePackage>
<SamplePackage/>
</NDC>