{
"NDC": {
"NDCCode": "68083-591-10",
"PackageDescription": "10 AMPULE in 1 BOX (68083-591-10) / 1 mL in 1 AMPULE",
"NDC11Code": "68083-0591-10",
"ProductNDC": "68083-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAMUSCULAR; INTRAOCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250603",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218144",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250603",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}