{
"NDC": {
"NDCCode": "0990-7965-09",
"PackageDescription": "12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
"NDC11Code": "00990-7965-09",
"ProductNDC": "0990-7965",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Normosol-m And Dextrose",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210208",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017610",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE",
"StrengthNumber": "5; 21; 128; 234",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210208",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}