<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
64950-290-16
</NDCCode>
<PackageDescription>
473 mL in 1 BOTTLE (64950-290-16)
</PackageDescription>
<NDC11Code>
64950-0290-16
</NDC11Code>
<ProductNDC>
64950-290
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Butalbital, Acetaminophen And Caffeine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Butalbital, Acetaminophen, And Caffeine
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250701
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA040387
</ApplicationNumber>
<LabelerName>
Genus Lifesciences Inc.
</LabelerName>
<SubstanceName>
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
</SubstanceName>
<StrengthNumber>
325; 50; 40
</StrengthNumber>
<StrengthUnit>
mg/15mL; mg/15mL; mg/15mL
</StrengthUnit>
<Pharm_Classes>
Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
</Pharm_Classes>
<DEASchedule>
CIII
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2025-07-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250701
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>