{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0990-7372",
      "generic_name": "DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
      "labeler_name": "ICU Medical Inc.",
      "brand_name": "Ionosol MB and Dextrose",
      "active_ingredients": [
        {
          "name": "DEXTROSE MONOHYDRATE",
          "strength": "5 g/100mL"
        },
        {
          "name": "SODIUM LACTATE",
          "strength": "260 mg/100mL"
        },
        {
          "name": "POTASSIUM CHLORIDE",
          "strength": "141 mg/100mL"
        },
        {
          "name": "MAGNESIUM CHLORIDE",
          "strength": "30 mg/100mL"
        },
        {
          "name": "MONOBASIC POTASSIUM PHOSPHATE",
          "strength": "15 mg/100mL"
        },
        {
          "name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
          "strength": "25 mg/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0990-7372-03",
          "description": "24 POUCH in 1 CASE (0990-7372-03)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
          "marketing_start_date": "20200101",
          "sample": false
        },
        {
          "package_ndc": "0990-7372-62",
          "description": "24 POUCH in 1 CASE (0990-7372-62)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
          "marketing_start_date": "20190701",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "ICU Medical Inc."
        ],
        "rxcui": [
          "800644",
          "800648"
        ],
        "spl_set_id": [
          "1b457b1d-0e80-4578-ba6f-dedf513fc962"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "LX22YL083G",
          "TU7HW0W0QT",
          "660YQ98I10",
          "02F3473H9O",
          "4J9FJ0HL51",
          "593YOG76RN"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "INJECTION, SOLUTION",
      "spl_id": "f6e10cf9-7244-440c-88a3-a100a51bb74c",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20190701",
      "product_id": "0990-7372_f6e10cf9-7244-440c-88a3-a100a51bb74c",
      "application_number": "NDA019513",
      "brand_name_base": "Ionosol MB and Dextrose",
      "pharm_class": [
        "Calculi Dissolution Agent [EPC]",
        "Increased Large Intestinal Motility [PE]",
        "Increased Large Intestinal Motility [PE]",
        "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 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 Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Potassium Compounds [CS]",
        "Potassium Compounds [CS]",
        "Potassium Salt [EPC]",
        "Potassium Salt [EPC]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
      ]
    }
  ]
}