{
"NDC": {
"NDCCode": "43598-908-56",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (43598-908-56) ",
"NDC11Code": "43598-0908-56",
"ProductNDC": "43598-908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241213",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215931",
"LabelerName": "Dr. Reddys Laboratories 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": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241213",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}