{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "50222-361",
      "generic_name": "spesolimab",
      "labeler_name": "LEO Pharma Inc.",
      "brand_name": "SPEVIGO",
      "active_ingredients": [
        {
          "name": "SPESOLIMAB",
          "strength": "150 mg/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "50222-361-02",
          "description": "2 SYRINGE, GLASS in 1 CARTON (50222-361-02)  / 1 mL in 1 SYRINGE, GLASS (50222-361-11)",
          "marketing_start_date": "20260309",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "LEO Pharma Inc."
        ],
        "rxcui": [
          "2610422",
          "2610428",
          "2678979",
          "2678984",
          "2716696",
          "2716697"
        ],
        "spl_set_id": [
          "78a4f7eb-8d34-4467-8d40-74ed24323806"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000194039",
          "N0000194040"
        ],
        "pharm_class_epc": [
          "Interleukin-36 Receptor Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Interleukin-36 Receptor Antagonists [MoA]"
        ],
        "unii": [
          "5IB2J79MCX"
        ]
      },
      "marketing_category": "BLA",
      "dosage_form": "INJECTION",
      "spl_id": "40cef378-e90e-4891-812a-b3c889dc9193",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "SUBCUTANEOUS"
      ],
      "marketing_start_date": "20260309",
      "product_id": "50222-361_40cef378-e90e-4891-812a-b3c889dc9193",
      "application_number": "BLA761244",
      "brand_name_base": "SPEVIGO",
      "pharm_class": [
        "Interleukin-36 Receptor Antagonist [EPC]",
        "Interleukin-36 Receptor Antagonists [MoA]"
      ]
    }
  ]
}