<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68084-213-01
</NDCCode>
<PackageDescription>
100 BLISTER PACK in 1 CARTON (68084-213-01) > 1 CAPSULE in 1 BLISTER PACK (68084-213-11)
</PackageDescription>
<NDC11Code>
68084-0213-01
</NDC11Code>
<ProductNDC>
68084-213
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ursodiol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ursodiol
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20091105
</StartMarketingDate>
<EndMarketingDate>
20170331
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA019594
</ApplicationNumber>
<LabelerName>
American Health Packaging
</LabelerName>
<SubstanceName>
URSODIOL
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-04-04
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>