{
"NDC": {
"NDCCode": "83301-0082-1",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (83301-0082-1) / .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "83301-0082-01",
"ProductNDC": "83301-0082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ganirelix Acetate",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Ganirelix Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260113",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218855",
"LabelerName": "Mullan Pharmaceutical Inc.",
"SubstanceName": "GANIRELIX ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260113",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}