{
  "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": "0338-1125",
      "generic_name": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "labeler_name": "Baxter Healthcare Company",
      "brand_name": "CLINIMIX E",
      "active_ingredients": [
        {
          "name": "LEUCINE",
          "strength": "365 mg/100mL"
        },
        {
          "name": "PHENYLALANINE",
          "strength": "280 mg/100mL"
        },
        {
          "name": "LYSINE",
          "strength": "290 mg/100mL"
        },
        {
          "name": "METHIONINE",
          "strength": "200 mg/100mL"
        },
        {
          "name": "ISOLEUCINE",
          "strength": "300 mg/100mL"
        },
        {
          "name": "VALINE",
          "strength": "290 mg/100mL"
        },
        {
          "name": "HISTIDINE",
          "strength": "240 mg/100mL"
        },
        {
          "name": "THREONINE",
          "strength": "210 mg/100mL"
        },
        {
          "name": "TRYPTOPHAN",
          "strength": "90 mg/100mL"
        },
        {
          "name": "ALANINE",
          "strength": "1035 mg/100mL"
        },
        {
          "name": "GLYCINE",
          "strength": "515 mg/100mL"
        },
        {
          "name": "ARGININE",
          "strength": "575 mg/100mL"
        },
        {
          "name": "PROLINE",
          "strength": "340 mg/100mL"
        },
        {
          "name": "SERINE",
          "strength": "250 mg/100mL"
        },
        {
          "name": "TYROSINE",
          "strength": "20 mg/100mL"
        },
        {
          "name": "SODIUM ACETATE",
          "strength": "340 mg/100mL"
        },
        {
          "name": "POTASSIUM PHOSPHATE, DIBASIC",
          "strength": "261 mg/100mL"
        },
        {
          "name": "MAGNESIUM CHLORIDE",
          "strength": "51 mg/100mL"
        },
        {
          "name": "SODIUM CHLORIDE",
          "strength": "59 mg/100mL"
        },
        {
          "name": "CALCIUM CHLORIDE",
          "strength": "33 mg/100mL"
        },
        {
          "name": "DEXTROSE",
          "strength": "20 g/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0338-1125-04",
          "description": "2000 mL in 1 BAG (0338-1125-04)",
          "marketing_start_date": "19970326",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Baxter Healthcare Company"
        ],
        "rxcui": [
          "800998",
          "801000",
          "801010",
          "801012",
          "801019",
          "801021",
          "801029",
          "801031",
          "1090635",
          "1090639"
        ],
        "spl_set_id": [
          "8469d6fb-d6ef-476f-8cc3-0905192de0a8"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]"
        ],
        "unii": [
          "TE7660XO1C",
          "8DUH1N11BX",
          "GMW67QNF9C",
          "94ZLA3W45F",
          "OF5P57N2ZX",
          "IY9XDZ35W2",
          "452VLY9402",
          "4550K0SC9B",
          "AE28F7PNPL",
          "HG18B9YRS7",
          "K3Z4F929H6",
          "04Y7590D77",
          "4QD397987E",
          "9DLQ4CIU6V",
          "47E5O17Y3R",
          "02F3473H9O",
          "2ZD004190S",
          "42HK56048U",
          "451W47IQ8X",
          "CI71S98N1Z",
          "M4I0D6VV5M"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "INJECTION",
      "spl_id": "c5f1da6b-9b01-4814-97a5-3d7efbedec9c",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "19970326",
      "product_id": "0338-1125_c5f1da6b-9b01-4814-97a5-3d7efbedec9c",
      "application_number": "NDA020678",
      "brand_name_base": "CLINIMIX E",
      "pharm_class": [
        "Amino Acid [EPC]",
        "Amino Acids [CS]",
        "Blood Coagulation Factor [EPC]",
        "Calcium [CS]",
        "Calculi Dissolution Agent [EPC]",
        "Cations",
        "Divalent [CS]",
        "Increased Coagulation Factor Activity [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 Small Intestine Fluid/Electrolyte Absorption [PE]",
        "Magnesium Ion Exchange Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Phosphate Binder [EPC]",
        "Phosphate Chelating Activity [MoA]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
      ]
    }
  ]
}