{
"NDC": {
"NDCCode": "69452-428-97",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 KIT (69452-428-97) / 177 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69452-0428-97",
"ProductNDC": "69452-428",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250415",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204135",
"LabelerName": "Bionpharma Inc.,",
"SubstanceName": "MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE",
"StrengthNumber": "1.6; 3.13; 17.5",
"StrengthUnit": "g/177mL; g/177mL; g/177mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], 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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"DEASchedule": null,
"Status": "Deprecated",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250415",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}