<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81033-019-01
</NDCCode>
<PackageDescription>
100 CUP, UNIT-DOSE in 1 CASE (81033-019-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-019-05)
</PackageDescription>
<NDC11Code>
81033-0019-01
</NDC11Code>
<ProductNDC>
81033-019
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Childrens Ibuprofen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ibuprofen
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20110428
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA074937
</ApplicationNumber>
<LabelerName>
Kesin Pharma Corporation
</LabelerName>
<SubstanceName>
IBUPROFEN
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-14
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251101
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>