{
"NDC": {
"NDCCode": "68083-587-01",
"PackageDescription": "1 VIAL in 1 CARTON (68083-587-01) / 17.5 mL in 1 VIAL",
"NDC11Code": "68083-0587-01",
"ProductNDC": "68083-587",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20251112",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218200",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "350",
"StrengthUnit": "mg/17.5mL",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251112",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}