{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "product_ndc": "49281-564",
      "generic_name": "diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine",
      "labeler_name": "Sanofi Vaccines US Inc.",
      "brand_name": "QUADRACEL",
      "active_ingredients": [
        {
          "name": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
          "strength": "15 [Lf]/.5mL"
        },
        {
          "name": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
          "strength": "5 [Lf]/.5mL"
        },
        {
          "name": "BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)",
          "strength": "20 ug/.5mL"
        },
        {
          "name": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
          "strength": "20 ug/.5mL"
        },
        {
          "name": "BORDETELLA PERTUSSIS PERTACTIN ANTIGEN",
          "strength": "3 ug/.5mL"
        },
        {
          "name": "BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN",
          "strength": "5 ug/.5mL"
        },
        {
          "name": "POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)",
          "strength": "29 [D'ag'U]/.5mL"
        },
        {
          "name": "POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)",
          "strength": "7 [D'ag'U]/.5mL"
        },
        {
          "name": "POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
          "strength": "26 [D'ag'U]/.5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "49281-564-10",
          "description": "10 VIAL, SINGLE-USE in 1 PACKAGE (49281-564-10)  / .5 mL in 1 VIAL, SINGLE-USE (49281-564-58)",
          "marketing_start_date": "20150324",
          "sample": false
        },
        {
          "package_ndc": "49281-564-15",
          "description": "10 SYRINGE in 1 PACKAGE (49281-564-15)  / .5 mL in 1 SYRINGE (49281-564-88)",
          "marketing_start_date": "20150324",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {},
      "marketing_category": "BLA",
      "dosage_form": "INJECTION, SUSPENSION",
      "spl_id": "b943f360-e126-45d4-af57-3fcb4c68d1b2",
      "product_type": "VACCINE",
      "route": [
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      ],
      "marketing_start_date": "20150324",
      "product_id": "49281-564_b943f360-e126-45d4-af57-3fcb4c68d1b2",
      "application_number": "BLA125525",
      "brand_name_base": "QUADRACEL",
      "pharm_class": [
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        "Actively Acquired Immunity [PE]",
        "Actively Acquired Immunity [PE]",
        "Actively Acquired Immunity [PE]",
        "Actively Acquired Immunity [PE]",
        "Actively Acquired Immunity [PE]",
        "Actively Acquired Immunity [PE]",
        "Actively Acquired Immunity [PE]",
        "Diphtheria Toxoid [CS]",
        "Inactivated Bordetella Pertussis Vaccine [EPC]",
        "Inactivated Bordetella Pertussis Vaccine [EPC]",
        "Inactivated Bordetella Pertussis Vaccine [EPC]",
        "Inactivated Clostridium Tetani Vaccine [EPC]",
        "Inactivated Corynebacterium Diphtheriae Vaccine [EPC]",
        "Inactivated Poliovirus Vaccine [EPC]",
        "Inactivated Poliovirus Vaccine [EPC]",
        "Inactivated Poliovirus Vaccine [EPC]",
        "Pertussis Vaccine [CS]",
        "Pertussis Vaccine [CS]",
        "Pertussis Vaccine [CS]",
        "Poliovirus Vaccines [CS]",
        "Poliovirus Vaccines [CS]",
        "Poliovirus Vaccines [CS]",
        "Tetanus Toxoid [CS]",
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        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]"
      ]
    }
  ]
}