<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
51167-100-01
</NDCCode>
<PackageDescription>
4 BOX in 1 CARTON (51167-100-01) > 7 BLISTER PACK in 1 BOX > 6 TABLET, FILM COATED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
51167-0100-01
</NDC11Code>
<ProductNDC>
51167-100
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Incivek
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Telaprevir
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20110523
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA201917
</ApplicationNumber>
<LabelerName>
Vertex Pharmaceuticals Incorporated
</LabelerName>
<SubstanceName>
TELAPREVIR
</SubstanceName>
<StrengthNumber>
375
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
HCV NS3/4A Protease Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2014-11-14
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>