{
"NDC": {
"NDCCode": "60290-078-01",
"PackageDescription": "56 TABLET in 1 BOTTLE (60290-078-01) ",
"NDC11Code": "60290-0078-01",
"ProductNDC": "60290-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Varenicline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260109",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218985",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260109",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}