{
"NDC": {
"NDCCode": "33342-546-53",
"PackageDescription": "2 BOTTLE in 1 CARTON (33342-546-53) / 177 mL in 1 BOTTLE (33342-546-23) ",
"NDC11Code": "33342-0546-53",
"ProductNDC": "33342-546",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260831",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219429",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE",
"StrengthNumber": "17.5; 3.13; 1.6",
"StrengthUnit": "g/177mL; g/177mL; g/177mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260831",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}