<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68788-9072-6
</NDCCode>
<PackageDescription>
60 mL in 1 BOTTLE, DROPPER (68788-9072-6)
</PackageDescription>
<NDC11Code>
68788-9072-06
</NDC11Code>
<ProductNDC>
68788-9072
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Nystatin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Nystatin
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20050628
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA065148
</ApplicationNumber>
<LabelerName>
Preferred Pharmaceuticals, Inc
</LabelerName>
<SubstanceName>
NYSTATIN
</SubstanceName>
<StrengthNumber>
100000
</StrengthNumber>
<StrengthUnit>
[USP'U]/mL
</StrengthUnit>
<Pharm_Classes>
Polyene Antifungal [EPC],Polyenes [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-11-09
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20201231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20050628
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>