{
  "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": "68788-4084",
      "generic_name": "Ketotifen Fumarate",
      "labeler_name": "Preferred Pharmaceuticals Inc.",
      "brand_name": "Ketotifen Fumarate Ophthalmic Solution",
      "active_ingredients": [
        {
          "name": "KETOTIFEN FUMARATE",
          "strength": ".25 mg/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "68788-4084-5",
          "description": "1 BOTTLE, DROPPER in 1 CARTON (68788-4084-5)  / 5 mL in 1 BOTTLE, DROPPER",
          "marketing_start_date": "20260227",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Preferred Pharmaceuticals Inc."
        ],
        "rxcui": [
          "311237"
        ],
        "spl_set_id": [
          "f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c"
        ],
        "unii": [
          "HBD503WORO"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SOLUTION/ DROPS",
      "spl_id": "95d70587-2cf2-4e14-8ca3-11b762f1188b",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "OPHTHALMIC"
      ],
      "marketing_start_date": "20260227",
      "product_id": "68788-4084_95d70587-2cf2-4e14-8ca3-11b762f1188b",
      "application_number": "ANDA077958",
      "brand_name_base": "Ketotifen Fumarate Ophthalmic Solution",
      "pharm_class": [
        "Histamine H1 Receptor Antagonists [MoA]",
        "Histamine-1 Receptor Inhibitor [EPC]"
      ]
    }
  ]
}