<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
54257-573-03
</NDCCode>
<PackageDescription>
200 TABLET in 1 BOTTLE (54257-573-03)
</PackageDescription>
<NDC11Code>
54257-0573-03
</NDC11Code>
<ProductNDC>
54257-573
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Acetaminophen Extended-release
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetaminophen
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20200124
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA211544
</ApplicationNumber>
<LabelerName>
Magno-Humphries, Inc.
</LabelerName>
<SubstanceName>
ACETAMINOPHEN
</SubstanceName>
<StrengthNumber>
650
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2021-11-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20200124
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>