{
"NDC": {
"NDCCode": "67877-890-88",
"PackageDescription": "1 POUCH in 1 CARTON (67877-890-88) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE",
"NDC11Code": "67877-0890-88",
"ProductNDC": "67877-890",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirabegron",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Mirabegron",
"DosageFormName": "FOR SUSPENSION, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260615",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219323",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "MIRABEGRON",
"StrengthNumber": "8",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}