<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
35573-108-14
</NDCCode>
<PackageDescription>
10 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14) / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13)
</PackageDescription>
<NDC11Code>
35573-0108-14
</NDC11Code>
<ProductNDC>
35573-108
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sodium Polystyrene Sulfonate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Polystyrene Sulfonate
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
ORAL; RECTAL
</RouteName>
<StartMarketingDate>
20251218
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214912
</ApplicationNumber>
<LabelerName>
Burel Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
SODIUM POLYSTYRENE SULFONATE
</SubstanceName>
<StrengthNumber>
15
</StrengthNumber>
<StrengthUnit>
g/60mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-20
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251218
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>