{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "63323-712",
      "generic_name": "Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine",
      "labeler_name": "Fresenius Kabi USA, LLC",
      "brand_name": "Kabiven",
      "active_ingredients": [
        {
          "name": "DEXTROSE MONOHYDRATE",
          "strength": "10.8 g/100mL"
        },
        {
          "name": "SOYBEAN OIL",
          "strength": "3.9 g/100mL"
        },
        {
          "name": "SODIUM ACETATE",
          "strength": "239 mg/100mL"
        },
        {
          "name": "POTASSIUM CHLORIDE",
          "strength": "174 mg/100mL"
        },
        {
          "name": "SODIUM GLYCEROPHOSPHATE ANHYDROUS",
          "strength": "147 mg/100mL"
        },
        {
          "name": "MAGNESIUM SULFATE HEPTAHYDRATE",
          "strength": "96 mg/100mL"
        },
        {
          "name": "CALCIUM CHLORIDE",
          "strength": "29 mg/100mL"
        },
        {
          "name": "LYSINE HYDROCHLORIDE",
          "strength": "263 mg/100mL"
        },
        {
          "name": "PHENYLALANINE",
          "strength": "231 mg/100mL"
        },
        {
          "name": "LEUCINE",
          "strength": "231 mg/100mL"
        },
        {
          "name": "VALINE",
          "strength": "213 mg/100mL"
        },
        {
          "name": "HISTIDINE",
          "strength": "199 mg/100mL"
        },
        {
          "name": "THREONINE",
          "strength": "164 mg/100mL"
        },
        {
          "name": "METHIONINE",
          "strength": "164 mg/100mL"
        },
        {
          "name": "ISOLEUCINE",
          "strength": "164 mg/100mL"
        },
        {
          "name": "TRYPTOPHAN",
          "strength": "55 mg/100mL"
        },
        {
          "name": "ALANINE",
          "strength": "467 mg/100mL"
        },
        {
          "name": "ARGININE",
          "strength": "330 mg/100mL"
        },
        {
          "name": "GLYCINE",
          "strength": "231 mg/100mL"
        },
        {
          "name": "PROLINE",
          "strength": "199 mg/100mL"
        },
        {
          "name": "GLUTAMIC ACID",
          "strength": "164 mg/100mL"
        },
        {
          "name": "SERINE",
          "strength": "131 mg/100mL"
        },
        {
          "name": "ASPARTIC ACID",
          "strength": "99 mg/100mL"
        },
        {
          "name": "TYROSINE",
          "strength": "6.7 mg/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "63323-712-10",
          "description": "1026 mL in 1 BAG (63323-712-10)",
          "marketing_start_date": "20140825",
          "sample": false
        },
        {
          "package_ndc": "63323-712-15",
          "description": "1540 mL in 1 BAG (63323-712-15)",
          "marketing_start_date": "20140825",
          "sample": false
        },
        {
          "package_ndc": "63323-712-20",
          "description": "2053 mL in 1 BAG (63323-712-20)",
          "marketing_start_date": "20140825",
          "sample": false
        },
        {
          "package_ndc": "63323-712-25",
          "description": "2566 mL in 1 BAG (63323-712-25)",
          "marketing_start_date": "20140825",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "spl_set_id": [
          "afeb4837-a759-4484-a76e-e04611c459e7"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323712105",
          "0363323712204",
          "0363323712150",
          "0363323712259"
        ],
        "nui": [
          "N0000191261",
          "M0012553",
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Lipid Emulsion [EPC]",
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Lipids [CS]",
          "Amino Acids [CS]"
        ],
        "unii": [
          "LX22YL083G",
          "241ATL177A",
          "4550K0SC9B",
          "660YQ98I10",
          "YP1H63LJ2K",
          "SK47B8698T",
          "M4I0D6VV5M",
          "JNJ23Q2COM",
          "47E5O17Y3R",
          "GMW67QNF9C",
          "HG18B9YRS7",
          "4QD397987E",
          "2ZD004190S",
          "AE28F7PNPL",
          "04Y7590D77",
          "8DUH1N11BX",
          "OF5P57N2ZX",
          "94ZLA3W45F",
          "TE7660XO1C",
          "9DLQ4CIU6V",
          "3KX376GY7L",
          "452VLY9402",
          "30KYC7MIAI",
          "42HK56048U"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "INJECTION, EMULSION",
      "spl_id": "f4e7d197-8c8f-4603-ae34-cd4c204d89c3",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20140825",
      "product_id": "63323-712_f4e7d197-8c8f-4603-ae34-cd4c204d89c3",
      "application_number": "NDA200656",
      "brand_name_base": "Kabiven",
      "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]",
        "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 Small Intestine Fluid/Electrolyte Absorption [PE]",
        "Lipid Emulsion [EPC]",
        "Lipids [CS]",
        "Magnesium Ion Exchange 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]",
        "Phosphate Binder [EPC]",
        "Phosphate Chelating Activity [MoA]",
        "Potassium Compounds [CS]",
        "Potassium Salt [EPC]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
      ]
    }
  ]
}