{
  "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": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0536-1252",
      "generic_name": "Ketotifen Fumarate",
      "labeler_name": "Rugby Laboratories",
      "brand_name": "Ketotifen Fumarate",
      "active_ingredients": [
        {
          "name": "KETOTIFEN FUMARATE",
          "strength": ".25 mg/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0536-1252-40",
          "description": "1 BOTTLE, DROPPER in 1 CARTON (0536-1252-40)  / 5 mL in 1 BOTTLE, DROPPER",
          "marketing_start_date": "20200918",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Rugby Laboratories"
        ],
        "rxcui": [
          "311237"
        ],
        "spl_set_id": [
          "8aa81ae9-112a-49fa-a0cb-ed0217a40de5"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "HBD503WORO"
        ]
      },
      "marketing_category": "NDA AUTHORIZED GENERIC",
      "dosage_form": "SOLUTION/ DROPS",
      "spl_id": "4d77465a-daa0-b622-e063-6294a90a7d81",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "OPHTHALMIC"
      ],
      "marketing_start_date": "20200918",
      "product_id": "0536-1252_4d77465a-daa0-b622-e063-6294a90a7d81",
      "application_number": "NDA021996",
      "brand_name_base": "Ketotifen Fumarate",
      "pharm_class": [
        "Histamine H1 Receptor Antagonists [MoA]",
        "Histamine-1 Receptor Inhibitor [EPC]"
      ]
    }
  ]
}