<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
69189-0587-1
</NDCCode>
<PackageDescription>
1 TABLET, COATED in 1 DOSE PACK (69189-0587-1)
</PackageDescription>
<NDC11Code>
69189-0587-01
</NDC11Code>
<ProductNDC>
69189-0587
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Nystatin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Nystatin
</NonProprietaryName>
<DosageFormName>
TABLET, COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20160321
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA062474
</ApplicationNumber>
<LabelerName>
Avera McKennan Hospital
</LabelerName>
<SubstanceName>
NYSTATIN
</SubstanceName>
<StrengthNumber>
500000
</StrengthNumber>
<StrengthUnit>
[USP'U]/1
</StrengthUnit>
<Pharm_Classes>
Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2018-06-14
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20181231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>