{
"NDC": {
"NDCCode": "81665-109-25",
"PackageDescription": "250 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-25) ",
"NDC11Code": "81665-0109-25",
"ProductNDC": "81665-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diethylpropion Hydrochloride",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Diethylpropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250919",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091680",
"LabelerName": "OMNIVIUM PHARMACEUTICALS LLC.",
"SubstanceName": "DIETHYLPROPION HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250919",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}