{
"NDC": {
"NDCCode": "53002-7044-3",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (53002-7044-3) ",
"NDC11Code": "53002-7044-03",
"ProductNDC": "53002-7044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Nitrofurantoin (monohydrate/macrocrystals)",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230914",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217357",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"DEASchedule": null,
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": null,
"StartMarketingDatePackage": "20240101",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N"
}
}