{
"NDC": {
"NDCCode": "69292-303-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (69292-303-01) ",
"NDC11Code": "69292-0303-01",
"ProductNDC": "69292-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital And Acetaminophen",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Butalbital And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260315",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214088",
"LabelerName": "Amici Pharma, Inc.",
"SubstanceName": "ACETAMINOPHEN; BUTALBITAL",
"StrengthNumber": "325; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260315",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}