<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82804-108-90
</NDCCode>
<PackageDescription>
90 TABLET in 1 BOTTLE (82804-108-90)
</PackageDescription>
<NDC11Code>
82804-0108-90
</NDC11Code>
<ProductNDC>
82804-108
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Isosorbide Dinitrate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Isosorbide Dinitrate
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20220708
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA215723
</ApplicationNumber>
<LabelerName>
Proficient Rx LP
</LabelerName>
<SubstanceName>
ISOSORBIDE DINITRATE
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-07-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240705
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>