{
  "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": "2026-10-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0990-7965",
      "generic_name": "dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate",
      "labeler_name": "ICU Medical Inc.",
      "brand_name": "NORMOSOL-M AND DEXTROSE",
      "active_ingredients": [
        {
          "name": "DEXTROSE MONOHYDRATE",
          "strength": "5 g/100mL"
        },
        {
          "name": "SODIUM CHLORIDE",
          "strength": "234 mg/100mL"
        },
        {
          "name": "POTASSIUM ACETATE",
          "strength": "128 mg/100mL"
        },
        {
          "name": "MAGNESIUM ACETATE",
          "strength": "21 mg/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0990-7965-09",
          "description": "12 POUCH in 1 CASE (0990-7965-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
          "marketing_start_date": "20210208",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "ICU Medical Inc."
        ],
        "rxcui": [
          "801005",
          "801009"
        ],
        "spl_set_id": [
          "aba60c84-94d9-46d0-bdbb-25e0c4e8cc41"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "LX22YL083G",
          "451W47IQ8X",
          "M911911U02",
          "0E95JZY48K"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "INJECTION, SOLUTION",
      "spl_id": "4c144127-6bca-4067-8d7a-75859a8e2aa5",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20210208",
      "product_id": "0990-7965_4c144127-6bca-4067-8d7a-75859a8e2aa5",
      "application_number": "NDA017610",
      "brand_name_base": "NORMOSOL-M AND DEXTROSE",
      "pharm_class": [
        "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]"
      ]
    }
  ]
}