{
"NDC": {
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"PackageDescription": "10 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0) ",
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"ProductNDC": "81092-1180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ProprietaryNameSuffix": null,
"NonProprietaryName": "Dexmedetomidine",
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"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20220701",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215390",
"LabelerName": "BioXcel Therapeutics, Inc.",
"SubstanceName": "DEXMEDETOMIDINE",
"StrengthNumber": "180",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220701",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}