{
  "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": "2026-09-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 9
    }
  },
  "results": [
    {
      "update_type": "Reverified",
      "initial_posting_date": "12/08/2020",
      "package_ndc": "0338-1130-03",
      "generic_name": "Amino Acid Injection",
      "contact_info": "888-229-0001",
      "availability": "Available",
      "openfda": {
        "application_number": [
          "ANDA075880"
        ],
        "brand_name": [
          "PREMASOL - SULFITE-FREE (AMINO ACID)"
        ],
        "generic_name": [
          "LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Company"
        ],
        "product_ndc": [
          "0338-1130",
          "0338-1131"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LEUCINE",
          "LYSINE ACETATE",
          "ISOLEUCINE",
          "VALINE",
          "HISTIDINE",
          "PHENYLALANINE",
          "THREONINE",
          "METHIONINE",
          "TRYPTOPHAN",
          "TYROSINE",
          "ARGININE",
          "PROLINE",
          "ALANINE",
          "GLUTAMIC ACID",
          "SERINE",
          "GLYCINE",
          "ASPARTIC ACID",
          "TAURINE",
          "CYSTEINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "801395",
          "801398",
          "801403",
          "801405"
        ],
        "spl_id": [
          "c874a813-b145-4f7f-833e-97d6c4dd727c"
        ],
        "spl_set_id": [
          "9afdcc3e-0d06-47f4-86ca-40da48b2b02b"
        ],
        "package_ndc": [
          "0338-1130-03",
          "0338-1130-04",
          "0338-1130-06",
          "0338-1131-03"
        ],
        "nui": [
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]"
        ],
        "unii": [
          "GMW67QNF9C",
          "TTL6G7LIWZ",
          "04Y7590D77",
          "HG18B9YRS7",
          "4QD397987E",
          "47E5O17Y3R",
          "2ZD004190S",
          "AE28F7PNPL",
          "8DUH1N11BX",
          "42HK56048U",
          "94ZLA3W45F",
          "9DLQ4CIU6V",
          "OF5P57N2ZX",
          "3KX376GY7L",
          "452VLY9402",
          "TE7660XO1C",
          "30KYC7MIAI",
          "1EQV5MLY3D",
          "ZT934N0X4W"
        ]
      },
      "update_date": "09/17/2026",
      "therapeutic_category": [
        "Gastroenterology"
      ],
      "dosage_form": "Injection",
      "presentation": "Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-03)",
      "company_name": "Baxter Healthcare",
      "status": "Current"
    }
  ]
}