{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 16
    }
  },
  "results": [
    {
      "update_type": "Reverified",
      "initial_posting_date": "12/08/2020",
      "package_ndc": "0990-4178-03",
      "generic_name": "Amino Acid Injection",
      "contact_info": "1-866-829-9025 or ProductAvailability@icumed.com",
      "availability": "Unavailable",
      "related_info": "Estimated recovery: TBD. This product is distributed by ICU Medical. For questions regarding this product, please contact ICU Medical.",
      "openfda": {
        "application_number": [
          "NDA019398"
        ],
        "brand_name": [
          "AMINOSYN-PF"
        ],
        "generic_name": [
          "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE"
        ],
        "manufacturer_name": [
          "ICU Medical Inc."
        ],
        "product_ndc": [
          "0990-4178"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ISOLEUCINE",
          "LEUCINE",
          "LYSINE ACETATE",
          "METHIONINE",
          "PHENYLALANINE",
          "THREONINE",
          "TRYPTOPHAN",
          "VALINE",
          "ALANINE",
          "ARGININE",
          "ASPARTIC ACID",
          "GLUTAMIC ACID",
          "GLYCINE",
          "HISTIDINE",
          "PROLINE",
          "SERINE",
          "TAURINE",
          "TYROSINE"
        ],
        "rxcui": [
          "831426",
          "831430"
        ],
        "spl_id": [
          "33d8e12a-620f-41d0-bdca-3a18fc0c20cb"
        ],
        "spl_set_id": [
          "2d212e10-7e08-4aeb-b63f-dcc927897769"
        ],
        "package_ndc": [
          "0990-4178-03"
        ],
        "nui": [
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]"
        ],
        "unii": [
          "04Y7590D77",
          "GMW67QNF9C",
          "TTL6G7LIWZ",
          "AE28F7PNPL",
          "47E5O17Y3R",
          "2ZD004190S",
          "8DUH1N11BX",
          "HG18B9YRS7",
          "OF5P57N2ZX",
          "94ZLA3W45F",
          "30KYC7MIAI",
          "3KX376GY7L",
          "TE7660XO1C",
          "4QD397987E",
          "9DLQ4CIU6V",
          "452VLY9402",
          "1EQV5MLY3D",
          "42HK56048U"
        ]
      },
      "update_date": "08/17/2026",
      "therapeutic_category": [
        "Gastroenterology"
      ],
      "dosage_form": "Injection",
      "presentation": "Aminosyn-PF 7%, Injection, 0.07 (NDC 0990-4178-03)",
      "company_name": "Otsuka ICU Medical LLC",
      "shortage_reason": "Shortage of an active ingredient",
      "status": "Current"
    }
  ]
}