<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81033-241-51
</NDCCode>
<PackageDescription>
100 CUP, UNIT-DOSE in 1 CASE (81033-241-51) / 30 mL in 1 CUP, UNIT-DOSE (81033-241-30)
</PackageDescription>
<NDC11Code>
81033-0241-51
</NDC11Code>
<ProductNDC>
81033-241
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Lactulose Solution
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lactulose Solution Usp, 10 G/15 Ml
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL; RECTAL
</RouteName>
<StartMarketingDate>
20210416
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA076645
</ApplicationNumber>
<LabelerName>
Kesin Pharma Corporation
</LabelerName>
<SubstanceName>
LACTULOSE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
g/15mL
</StrengthUnit>
<Pharm_Classes>
Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-12-07
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240416
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>