{
"NDC": {
"NDCCode": "82686-300-01",
"PackageDescription": "1 TRAY in 1 BOX, UNIT-DOSE (82686-300-01) / 1 INTRAUTERINE DEVICE in 1 TRAY",
"NDC11Code": "82686-0300-01",
"ProductNDC": "82686-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Miudella",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Copper",
"DosageFormName": "INTRAUTERINE DEVICE",
"RouteName": "INTRAUTERINE",
"StartMarketingDate": "20251001",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218201",
"LabelerName": "Sebela Women's Health Inc.",
"SubstanceName": "COPPER",
"StrengthNumber": "175",
"StrengthUnit": "mm/1",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251001",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}