{
  "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,
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    }
  },
  "results": [
    {
      "product_ndc": "68982-261",
      "generic_name": "Prothrombin Complex Concentrate (Human)",
      "labeler_name": "Octapharma USA Inc",
      "brand_name": "Balfaxar",
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        {
          "name": "COAGULATION FACTOR IX HUMAN",
          "strength": "25.5 [iU]/mL"
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        {
          "name": "COAGULATION FACTOR VII HUMAN",
          "strength": "16.5 [iU]/mL"
        },
        {
          "name": "COAGULATION FACTOR X HUMAN",
          "strength": "24 [iU]/mL"
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        {
          "name": "PROTEIN C",
          "strength": "22 [iU]/mL"
        },
        {
          "name": "PROTEIN S HUMAN",
          "strength": "22 [iU]/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "68982-261-01",
          "description": "1 VIAL, GLASS in 1 CARTON (68982-261-01)  / 20 mL in 1 VIAL, GLASS (68982-261-81)",
          "marketing_start_date": "20231130",
          "sample": false
        },
        {
          "package_ndc": "68982-261-02",
          "description": "1 VIAL, GLASS in 1 CARTON (68982-261-02)  / 40 mL in 1 VIAL, GLASS (68982-261-82)",
          "marketing_start_date": "20231130",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {},
      "marketing_category": "BLA",
      "dosage_form": "POWDER, FOR SOLUTION",
      "spl_id": "5be10bd2-a785-7f3b-0d28-d066cd5f7d24",
      "product_type": "PLASMA DERIVATIVE",
      "route": [
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      "marketing_start_date": "20231130",
      "product_id": "68982-261_5be10bd2-a785-7f3b-0d28-d066cd5f7d24",
      "application_number": "BLA125776",
      "brand_name_base": "Balfaxar",
      "pharm_class": [
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        "Blood Coagulation Factor [EPC]",
        "Blood Coagulation Factors [CS]",
        "Blood Coagulation Factors [CS]",
        "Blood Coagulation Factors [CS]",
        "Blood Coagulation Factors [CS]",
        "Decreased Coagulation Factor Activity [PE]",
        "Enzyme Precursors [CS]",
        "Human Blood Coagulation Factor [EPC]",
        "Human Blood Coagulation Factor [EPC]",
        "Human Blood Coagulation Factor [EPC]",
        "Increased Coagulation Activity [PE]",
        "Increased Coagulation Activity [PE]",
        "Increased Coagulation Activity [PE]",
        "Increased Coagulation Activity [PE]",
        "Protein C [CS]"
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}