{
"NDC": {
"NDCCode": "55150-259-30",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 CARTON (55150-259-30) / 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0259-30",
"ProductNDC": "55150-259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160229",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207358",
"LabelerName": "Eugia US LLC",
"SubstanceName": "ACETYLCYSTEINE",
"StrengthNumber": "6",
"StrengthUnit": "g/30mL",
"Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160229",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}