{
"NDC": {
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"PackageDescription": "10 VIAL in 1 CARTON (68083-451-10) / 5 mL in 1 VIAL (68083-451-01) ",
"NDC11Code": "68083-0451-10",
"ProductNDC": "68083-451",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Sodium",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Esomeprazole Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200401",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203349",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "ESOMEPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200401",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}