{
"NDC": {
"NDCCode": "70069-788-04",
"PackageDescription": "4 VIAL in 1 CARTON (70069-788-04) / 30 mL in 1 VIAL",
"NDC11Code": "70069-0788-04",
"ProductNDC": "70069-788",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240613",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218397",
"LabelerName": "Somerset Therapeutics, 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": "2024-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240613",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}