<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
51991-728-67
</NDCCode>
<PackageDescription>
7 BOTTLE, WITH APPLICATOR in 1 BOX (51991-728-67) > 60 mL in 1 BOTTLE, WITH APPLICATOR (51991-728-99)
</PackageDescription>
<NDC11Code>
51991-0728-67
</NDC11Code>
<ProductNDC>
51991-728
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Hydrocortisone
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Hydrocortisone
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
RECTAL
</RouteName>
<StartMarketingDate>
20101015
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA016199
</ApplicationNumber>
<LabelerName>
Breckenridge Pharmaceutical, Inc.
</LabelerName>
<SubstanceName>
HYDROCORTISONE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/60mL
</StrengthUnit>
<Pharm_Classes>
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2016-12-02
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>