{
"NDC": {
"NDCCode": "85742-016-16",
"PackageDescription": "1 BLISTER PACK in 1 BOX (85742-016-16) / 56 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "85742-0016-16",
"ProductNDC": "85742-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217151",
"LabelerName": "Kanchan Healthcare Inc",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/561",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}