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