{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0338-0202",
      "generic_name": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "labeler_name": "Baxter Healthcare Company",
      "brand_name": "CLINIMIX E",
      "active_ingredients": [
        {
          "name": "LEUCINE",
          "strength": "584 mg/100mL"
        },
        {
          "name": "PHENYLALANINE",
          "strength": "448 mg/100mL"
        },
        {
          "name": "LYSINE",
          "strength": "464 mg/100mL"
        },
        {
          "name": "METHIONINE",
          "strength": "320 mg/100mL"
        },
        {
          "name": "ISOLEUCINE",
          "strength": "480 mg/100mL"
        },
        {
          "name": "VALINE",
          "strength": "464 mg/100mL"
        },
        {
          "name": "HISTIDINE",
          "strength": "384 mg/100mL"
        },
        {
          "name": "THREONINE",
          "strength": "336 mg/100mL"
        },
        {
          "name": "TRYPTOPHAN",
          "strength": "144 mg/100mL"
        },
        {
          "name": "ALANINE",
          "strength": "1656 mg/100mL"
        },
        {
          "name": "GLYCINE",
          "strength": "824 mg/100mL"
        },
        {
          "name": "ARGININE",
          "strength": "920 mg/100mL"
        },
        {
          "name": "PROLINE",
          "strength": "544 mg/100mL"
        },
        {
          "name": "SERINE",
          "strength": "400 mg/100mL"
        },
        {
          "name": "TYROSINE",
          "strength": "32 mg/100mL"
        },
        {
          "name": "POTASSIUM PHOSPHATE, DIBASIC",
          "strength": "261 mg/100mL"
        },
        {
          "name": "MAGNESIUM CHLORIDE",
          "strength": "51 mg/100mL"
        },
        {
          "name": "SODIUM CHLORIDE",
          "strength": "205 mg/100mL"
        },
        {
          "name": "CALCIUM CHLORIDE",
          "strength": "33 mg/100mL"
        },
        {
          "name": "DEXTROSE",
          "strength": "14 g/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0338-0202-06",
          "description": "6 BAG in 1 CARTON (0338-0202-06)  / 1000 mL in 1 BAG (0338-0202-01)",
          "marketing_start_date": "20200921",
          "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": [
          "OF5P57N2ZX",
          "451W47IQ8X",
          "9DLQ4CIU6V",
          "04Y7590D77",
          "TE7660XO1C",
          "47E5O17Y3R",
          "94ZLA3W45F",
          "452VLY9402",
          "2ZD004190S",
          "42HK56048U",
          "HG18B9YRS7",
          "02F3473H9O",
          "K3Z4F929H6",
          "4550K0SC9B",
          "M4I0D6VV5M",
          "8DUH1N11BX",
          "IY9XDZ35W2",
          "GMW67QNF9C",
          "AE28F7PNPL",
          "CI71S98N1Z",
          "4QD397987E"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "INJECTION",
      "spl_id": "c5f1da6b-9b01-4814-97a5-3d7efbedec9c",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20200921",
      "product_id": "0338-0202_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]"
      ]
    }
  ]
}