{
"NDC": {
"NDCCode": "42494-436-25",
"PackageDescription": "25 VIAL in 1 CARTON (42494-436-25) / 4 mL in 1 VIAL",
"NDC11Code": "42494-0436-25",
"ProductNDC": "42494-436",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20250821",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214177",
"LabelerName": "Cameron Pharmaceuticals",
"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": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250821",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}