<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0884-0396-02
</NDCCode>
<PackageDescription>
56.7 g in 1 BOTTLE, PLASTIC (0884-0396-02)
</PackageDescription>
<NDC11Code>
00884-0396-02
</NDC11Code>
<ProductNDC>
0884-0396
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Pedi-dri
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Nystatin
</NonProprietaryName>
<DosageFormName>
POWDER
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
19960816
</StartMarketingDate>
<EndMarketingDate>
20150630
</EndMarketingDate>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA064118
</ApplicationNumber>
<LabelerName>
Pedinol Pharmacal, Inc.
</LabelerName>
<SubstanceName>
NYSTATIN
</SubstanceName>
<StrengthNumber>
100000
</StrengthNumber>
<StrengthUnit>
[USP'U]/g
</StrengthUnit>
<Pharm_Classes>
Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2015-07-03
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>