<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43353-059-17
</NDCCode>
<PackageDescription>
6030 TABLET in 1 BOTTLE (43353-059-17)
</PackageDescription>
<NDC11Code>
43353-0059-17
</NDC11Code>
<ProductNDC>
43353-059
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Valsartan
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Valsartan
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20140707
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA021283
</ApplicationNumber>
<LabelerName>
Aphena Pharma Solutions - Tennessee, LLC
</LabelerName>
<SubstanceName>
VALSARTAN
</SubstanceName>
<StrengthNumber>
160
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2016-12-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20150531
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>