{
"NDC": {
"NDCCode": "58844-130-01",
"PackageDescription": "1 POUCH in 1 CARTON (58844-130-01) / 60 mg in 1 POUCH",
"NDC11Code": "58844-0130-01",
"ProductNDC": "58844-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macrilen",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Macimorelin Acetate",
"DosageFormName": "GRANULE, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180129",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205598",
"LabelerName": "Aeterna Zentaris GmbH",
"SubstanceName": "MACIMORELIN",
"StrengthNumber": "60",
"StrengthUnit": "mg/1817mg",
"Pharm_Classes": "Growth Hormone Secretagogue Receptor Agonist [EPC], Growth Hormone Secretagogue Receptor Agonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180129",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}