<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0832-0817-30
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (0832-0817-30) / 30 TABLET in 1 BOTTLE
</PackageDescription>
<NDC11Code>
00832-0817-30
</NDC11Code>
<ProductNDC>
0832-0817
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Deflazacort
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Deflazacort
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20241105
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA216720
</ApplicationNumber>
<LabelerName>
Upsher-Smith Laboratories, LLC
</LabelerName>
<SubstanceName>
DEFLAZACORT
</SubstanceName>
<StrengthNumber>
36
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-06-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250117
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>