{
"NDC": {
"NDCCode": "68083-657-10",
"PackageDescription": "10 POUCH in 1 CARTON (68083-657-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG",
"NDC11Code": "68083-0657-10",
"ProductNDC": "68083-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241219",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209307",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241219",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}