<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
80005-126-25
</NDCCode>
<PackageDescription>
280 CAPSULE in 1 BOTTLE (80005-126-25)
</PackageDescription>
<NDC11Code>
80005-0126-25
</NDC11Code>
<ProductNDC>
80005-126
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Balsalazide Disodium
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Balsalazide Disodium
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250630
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA219422
</ApplicationNumber>
<LabelerName>
Carnegie Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
BALSALAZIDE DISODIUM
</SubstanceName>
<StrengthNumber>
750
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-06-30
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250630
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>