{
"NDC": {
"NDCCode": "80425-0593-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (80425-0593-1) ",
"NDC11Code": "80425-0593-01",
"ProductNDC": "80425-0593",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramelteon",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260727",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215243",
"LabelerName": "Advanced Rx of Tennessee, LLC",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260727",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}