<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68998-401-03
</NDCCode>
<PackageDescription>
1 BOTTLE, PLASTIC in 1 CARTON (68998-401-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
</PackageDescription>
<NDC11Code>
68998-0401-03
</NDC11Code>
<ProductNDC>
68998-401
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
8 Hour Arthritis Pain
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetaminophen
</NonProprietaryName>
<DosageFormName>
TABLET, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20221005
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA211544
</ApplicationNumber>
<LabelerName>
MARC GLASSMAN, INC.
</LabelerName>
<SubstanceName>
ACETAMINOPHEN
</SubstanceName>
<StrengthNumber>
650
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2023-11-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20221005
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>