{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0338-1130",
      "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",
      "labeler_name": "Baxter Healthcare Company",
      "brand_name": "Premasol - sulfite-free (Amino Acid)",
      "active_ingredients": [
        {
          "name": "LEUCINE",
          "strength": "1.4 g/100mL"
        },
        {
          "name": "LYSINE ACETATE",
          "strength": ".82 g/100mL"
        },
        {
          "name": "ISOLEUCINE",
          "strength": ".82 g/100mL"
        },
        {
          "name": "VALINE",
          "strength": ".78 g/100mL"
        },
        {
          "name": "HISTIDINE",
          "strength": ".48 g/100mL"
        },
        {
          "name": "PHENYLALANINE",
          "strength": ".48 g/100mL"
        },
        {
          "name": "THREONINE",
          "strength": ".42 g/100mL"
        },
        {
          "name": "METHIONINE",
          "strength": ".34 g/100mL"
        },
        {
          "name": "TRYPTOPHAN",
          "strength": ".2 g/100mL"
        },
        {
          "name": "TYROSINE",
          "strength": ".24 g/100mL"
        },
        {
          "name": "ARGININE",
          "strength": "1.2 g/100mL"
        },
        {
          "name": "PROLINE",
          "strength": ".68 g/100mL"
        },
        {
          "name": "ALANINE",
          "strength": ".54 g/100mL"
        },
        {
          "name": "GLUTAMIC ACID",
          "strength": ".5 g/100mL"
        },
        {
          "name": "SERINE",
          "strength": ".38 g/100mL"
        },
        {
          "name": "GLYCINE",
          "strength": ".36 g/100mL"
        },
        {
          "name": "ASPARTIC ACID",
          "strength": ".32 g/100mL"
        },
        {
          "name": "TAURINE",
          "strength": "25 mg/100mL"
        },
        {
          "name": "CYSTEINE HYDROCHLORIDE",
          "strength": ".016 g/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0338-1130-03",
          "description": "500 mL in 1 BAG (0338-1130-03)",
          "marketing_start_date": "20030619",
          "sample": false
        },
        {
          "package_ndc": "0338-1130-04",
          "description": "1000 mL in 1 BAG (0338-1130-04)",
          "marketing_start_date": "20030619",
          "sample": false
        },
        {
          "package_ndc": "0338-1130-06",
          "description": "2000 mL in 1 BAG (0338-1130-06)",
          "marketing_start_date": "20030619",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Baxter Healthcare Company"
        ],
        "rxcui": [
          "801395",
          "801398",
          "801403",
          "801405"
        ],
        "spl_set_id": [
          "9afdcc3e-0d06-47f4-86ca-40da48b2b02b"
        ],
        "is_original_packager": [
          true
        ],
        "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"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "INJECTION, SOLUTION",
      "spl_id": "c874a813-b145-4f7f-833e-97d6c4dd727c",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20030619",
      "product_id": "0338-1130_c874a813-b145-4f7f-833e-97d6c4dd727c",
      "application_number": "ANDA075880",
      "brand_name_base": "Premasol - sulfite-free (Amino Acid)",
      "pharm_class": [
        "Amino Acid [EPC]",
        "Amino Acids [CS]"
      ]
    }
  ]
}