{
  "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": "2026-10-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0264-4500",
      "generic_name": "LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE",
      "labeler_name": "B. Braun Medical Inc.",
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      "active_ingredients": [
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          "name": "LYSINE ACETATE",
          "strength": "1.18 g/100mL"
        },
        {
          "name": "LEUCINE",
          "strength": "1.04 g/100mL"
        },
        {
          "name": "PHENYLALANINE",
          "strength": "1.04 g/100mL"
        },
        {
          "name": "VALINE",
          "strength": "960 mg/100mL"
        },
        {
          "name": "ISOLEUCINE",
          "strength": "749 mg/100mL"
        },
        {
          "name": "METHIONINE",
          "strength": "749 mg/100mL"
        },
        {
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          "strength": "749 mg/100mL"
        },
        {
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          "strength": "250 mg/100mL"
        },
        {
          "name": "ALANINE",
          "strength": "2.17 g/100mL"
        },
        {
          "name": "ARGININE",
          "strength": "1.47 g/100mL"
        },
        {
          "name": "GLYCINE",
          "strength": "1.04 g/100mL"
        },
        {
          "name": "HISTIDINE",
          "strength": "894 mg/100mL"
        },
        {
          "name": "PROLINE",
          "strength": "894 mg/100mL"
        },
        {
          "name": "GLUTAMIC ACID",
          "strength": "749 mg/100mL"
        },
        {
          "name": "SERINE",
          "strength": "592 mg/100mL"
        },
        {
          "name": "ASPARTIC ACID",
          "strength": "434 mg/100mL"
        },
        {
          "name": "TYROSINE",
          "strength": "39 mg/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0264-4500-00",
          "description": "8 CONTAINER in 1 CASE (0264-4500-00)  / 1000 mL in 1 CONTAINER",
          "marketing_start_date": "20180928",
          "sample": false
        },
        {
          "package_ndc": "0264-4500-05",
          "description": "4 CONTAINER in 1 CASE (0264-4500-05)  / 2000 mL in 1 CONTAINER",
          "marketing_start_date": "20191029",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
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        ],
        "rxcui": [
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        ],
        "spl_set_id": [
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        ],
        "is_original_packager": [
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        ],
        "nui": [
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]"
        ],
        "unii": [
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          "HG18B9YRS7",
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        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SOLUTION",
      "spl_id": "905f7c55-bf0d-4150-90ef-e8f1a5455bc1",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20180928",
      "product_id": "0264-4500_905f7c55-bf0d-4150-90ef-e8f1a5455bc1",
      "application_number": "ANDA091112",
      "brand_name_base": "Plenamine",
      "pharm_class": [
        "Amino Acid [EPC]",
        "Amino Acids [CS]"
      ]
    }
  ]
}