{
  "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": "2026-10-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "63323-820",
      "generic_name": "Smoflipid",
      "labeler_name": "Fresenius Kabi USA, LLC",
      "brand_name": "Smoflipid",
      "active_ingredients": [
        {
          "name": "SOYBEAN OIL",
          "strength": "6 g/100mL"
        },
        {
          "name": "MEDIUM-CHAIN TRIGLYCERIDES",
          "strength": "6 g/100mL"
        },
        {
          "name": "OLIVE OIL",
          "strength": "5 g/100mL"
        },
        {
          "name": "FISH OIL",
          "strength": "3 g/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "63323-820-00",
          "description": "10 BAG in 1 CASE (63323-820-00)  / 100 mL in 1 BAG (63323-820-01)",
          "marketing_start_date": "20160713",
          "sample": false
        },
        {
          "package_ndc": "63323-820-10",
          "description": "6 BAG in 1 CASE (63323-820-10)  / 1000 mL in 1 BAG (63323-820-05)",
          "marketing_start_date": "20190527",
          "sample": false
        },
        {
          "package_ndc": "63323-820-12",
          "description": "20 BAG in 1 CASE (63323-820-12)  / 100 mL in 1 BAG (63323-820-02)",
          "marketing_start_date": "20160713",
          "sample": false
        },
        {
          "package_ndc": "63323-820-50",
          "description": "12 BAG in 1 CASE (63323-820-50)  / 500 mL in 1 BAG (63323-820-03)",
          "marketing_start_date": "20160713",
          "sample": false
        },
        {
          "package_ndc": "63323-820-74",
          "description": "10 BAG in 1 CASE (63323-820-74)  / 250 mL in 1 BAG (63323-820-04)",
          "marketing_start_date": "20160713",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "spl_set_id": [
          "e0e9d917-ff6f-488e-a6a8-0ad59dd17d80"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000191261",
          "M0012553"
        ],
        "pharm_class_epc": [
          "Lipid Emulsion [EPC]"
        ],
        "pharm_class_cs": [
          "Lipids [CS]"
        ],
        "unii": [
          "241ATL177A",
          "C9H2L21V7U",
          "6UYK2W1W1E",
          "XGF7L72M0F"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "INJECTION, EMULSION",
      "spl_id": "9fd35691-76ee-486c-bd65-b47d3df2fef4",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20160713",
      "product_id": "63323-820_9fd35691-76ee-486c-bd65-b47d3df2fef4",
      "application_number": "NDA207648",
      "brand_name_base": "Smoflipid",
      "pharm_class": [
        "Lipid Emulsion [EPC]",
        "Lipid Emulsion [EPC]",
        "Lipids [CS]",
        "Lipids [CS]"
      ]
    }
  ]
}