{
  "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": "0944-2850",
      "generic_name": "Immune Globulin Subcutaneous (Human)",
      "labeler_name": "Takeda Pharmaceuticals America, Inc.",
      "brand_name": "CUVITRU",
      "active_ingredients": [
        {
          "name": "HUMAN IMMUNOGLOBULIN G",
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      "finished": true,
      "packaging": [
        {
          "package_ndc": "0944-2850-01",
          "description": "1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-01)  / 5 mL in 1 VIAL, SINGLE-USE (0944-2850-02)",
          "marketing_start_date": "20161018",
          "sample": false
        },
        {
          "package_ndc": "0944-2850-03",
          "description": "1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-03)  / 10 mL in 1 VIAL, SINGLE-USE (0944-2850-04)",
          "marketing_start_date": "20161018",
          "sample": false
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        {
          "package_ndc": "0944-2850-05",
          "description": "1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-05)  / 20 mL in 1 VIAL, SINGLE-USE (0944-2850-06)",
          "marketing_start_date": "20161018",
          "sample": false
        },
        {
          "package_ndc": "0944-2850-07",
          "description": "1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-07)  / 40 mL in 1 VIAL, SINGLE-USE (0944-2850-08)",
          "marketing_start_date": "20161018",
          "sample": false
        },
        {
          "package_ndc": "0944-2850-09",
          "description": "1 BOTTLE, GLASS in 1 CARTON (0944-2850-09)  / 50 mL in 1 BOTTLE, GLASS (0944-2850-10)",
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      ],
      "listing_expiration_date": "20261231",
      "openfda": {},
      "marketing_category": "BLA",
      "dosage_form": "INJECTION, SOLUTION",
      "spl_id": "195585b0-5cd1-4638-9765-224db70d6e44",
      "product_type": "PLASMA DERIVATIVE",
      "route": [
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      ],
      "marketing_start_date": "20161018",
      "product_id": "0944-2850_195585b0-5cd1-4638-9765-224db70d6e44",
      "application_number": "BLA125596",
      "brand_name_base": "CUVITRU",
      "pharm_class": [
        "Antigen Neutralization [MoA]",
        "Human Immunoglobulin G [EPC]",
        "Immunoglobulins [CS]",
        "Passively Acquired Immunity [PE]"
      ]
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}