<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0722-7075-01
</NDCCode>
<PackageDescription>
100 TABLET in 1 BOTTLE, PLASTIC (0722-7075-01)
</PackageDescription>
<NDC11Code>
00722-7075-01
</NDC11Code>
<ProductNDC>
0722-7075
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Butalbital And Acetaminophen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Butalbital And Acetaminophen
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20110823
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA090956
</ApplicationNumber>
<LabelerName>
Nexgen Pharma, Inc.
</LabelerName>
<SubstanceName>
BUTALBITAL; ACETAMINOPHEN
</SubstanceName>
<StrengthNumber>
50; 300
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Barbiturates [CS],Barbiturate [EPC]
</Pharm_Classes>
<DEASchedule>
CIII
</DEASchedule>
<Status>
Deprecated
</Status>
<LastUpdate>
2021-01-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20201231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20110823
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>