{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "49281-286",
      "generic_name": "corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen",
      "labeler_name": "Sanofi Vaccines US Inc.",
      "brand_name": "DAPTACEL",
      "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": "10 ug/.5mL"
        },
        {
          "name": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
          "strength": "5 ug/.5mL"
        },
        {
          "name": "BORDETELLA PERTUSSIS PERTACTIN ANTIGEN",
          "strength": "3 ug/.5mL"
        },
        {
          "name": "BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN",
          "strength": "5 ug/.5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "49281-286-01",
          "description": "1 VIAL in 1 PACKAGE (49281-286-01)  / .5 mL in 1 VIAL (49281-286-58)",
          "marketing_start_date": "20020514",
          "sample": false
        },
        {
          "package_ndc": "49281-286-05",
          "description": "5 VIAL in 1 PACKAGE (49281-286-05)  / .5 mL in 1 VIAL (49281-286-58)",
          "marketing_start_date": "20020514",
          "sample": false
        },
        {
          "package_ndc": "49281-286-10",
          "description": "10 VIAL in 1 PACKAGE (49281-286-10)  / .5 mL in 1 VIAL (49281-286-58)",
          "marketing_start_date": "20020514",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {},
      "marketing_category": "BLA",
      "dosage_form": "INJECTION, SUSPENSION",
      "spl_id": "73caea6f-276f-4e9f-967c-7bf522b68ba1",
      "product_type": "VACCINE",
      "route": [
        "INTRAMUSCULAR"
      ],
      "marketing_start_date": "20020514",
      "product_id": "49281-286_73caea6f-276f-4e9f-967c-7bf522b68ba1",
      "application_number": "BLA103666",
      "brand_name_base": "DAPTACEL",
      "pharm_class": [
        "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]",
        "Pertussis Vaccine [CS]",
        "Pertussis Vaccine [CS]",
        "Pertussis Vaccine [CS]",
        "Tetanus Toxoid [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]",
        "Vaccines",
        "Inactivated [CS]"
      ]
    }
  ]
}