<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
35573-456-00
</NDCCode>
<PackageDescription>
100 TABLET in 1 BOTTLE (35573-456-00)
</PackageDescription>
<NDC11Code>
35573-0456-00
</NDC11Code>
<ProductNDC>
35573-456
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Butalbital And Acetaminophen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Butalbital And Acetaminophen
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20221201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214088
</ApplicationNumber>
<LabelerName>
Burel Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
ACETAMINOPHEN; BUTALBITAL
</SubstanceName>
<StrengthNumber>
325; 50
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Barbiturate [EPC], Barbiturates [CS]
</Pharm_Classes>
<DEASchedule>
CIII
</DEASchedule>
<Status>
Deprecated
</Status>
<LastUpdate>
2022-12-20
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20231231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20221201
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>