{
  "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": "2026-09-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "63323-193",
      "generic_name": "IRINOTECAN HYDROCHLORIDE",
      "labeler_name": "Fresenius Kabi USA, LLC",
      "brand_name": "Irinotecan Hydrochloride",
      "active_ingredients": [
        {
          "name": "IRINOTECAN HYDROCHLORIDE",
          "strength": "20 mg/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "63323-193-52",
          "description": "1 VIAL in 1 BOX (63323-193-52)  / 2 mL in 1 VIAL",
          "marketing_start_date": "20090401",
          "sample": false
        },
        {
          "package_ndc": "63323-193-55",
          "description": "1 VIAL in 1 BOX (63323-193-55)  / 5 mL in 1 VIAL",
          "marketing_start_date": "20090401",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "rxcui": [
          "1726319",
          "1726324"
        ],
        "spl_set_id": [
          "ee45f127-8450-4455-a945-a1f5707f1d39"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323193522",
          "0363323193553"
        ],
        "unii": [
          "042LAQ1IIS"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "INJECTION, SOLUTION",
      "spl_id": "4e0a18c8-35aa-447c-bd91-b81d7d494d8e",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20090401",
      "product_id": "63323-193_4e0a18c8-35aa-447c-bd91-b81d7d494d8e",
      "application_number": "ANDA077776",
      "brand_name_base": "Irinotecan Hydrochloride",
      "pharm_class": [
        "Topoisomerase Inhibitor [EPC]",
        "Topoisomerase Inhibitors [MoA]"
      ]
    }
  ]
}