{
"NDC": {
"NDCCode": "70594-111-02",
"PackageDescription": "4 VIAL in 1 CARTON (70594-111-02) / 30 mL in 1 VIAL (70594-111-01) ",
"NDC11Code": "70594-0111-02",
"ProductNDC": "70594-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230610",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217182",
"LabelerName": "Xellia Pharmaceuticals USA LLC",
"SubstanceName": "ACETYLCYSTEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"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": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230610",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}