<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61010-4411-1
</NDCCode>
<PackageDescription>
50 POUCH in 1 CARTON (61010-4411-1) > 2 TABLET in 1 POUCH (61010-4411-0)
</PackageDescription>
<NDC11Code>
61010-4411-01
</NDC11Code>
<ProductNDC>
61010-4411
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Ibuprofen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ibuprofen
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20191230
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH NOT FINAL
</MarketingCategoryName>
<ApplicationNumber>
part343
</ApplicationNumber>
<LabelerName>
Safetec of America, Inc.
</LabelerName>
<SubstanceName>
IBUPROFEN
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2024-01-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20231231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20191230
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>