<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
49884-105-11
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (49884-105-11) > 30 TABLET, FILM COATED in 1 BOTTLE
</PackageDescription>
<NDC11Code>
49884-0105-11
</NDC11Code>
<ProductNDC>
49884-105
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Entecavir
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Entecavir
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20140818
</StartMarketingDate>
<EndMarketingDate>
20170831
</EndMarketingDate>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA021797
</ApplicationNumber>
<LabelerName>
Par Pharmaceutical Inc.
</LabelerName>
<SubstanceName>
ENTECAVIR
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-09-01
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>