{
  "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": "54092-476",
      "generic_name": "mesalamine",
      "labeler_name": "Takeda Pharmaceuticals America, Inc.",
      "brand_name": "Lialda",
      "active_ingredients": [
        {
          "name": "MESALAMINE",
          "strength": "1.2 g/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "54092-476-01",
          "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)",
          "marketing_start_date": "20070116",
          "sample": false
        },
        {
          "package_ndc": "54092-476-02",
          "description": "12 BOTTLE in 1 CARTON (54092-476-02)  / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)",
          "marketing_start_date": "20070116",
          "sample": false
        },
        {
          "package_ndc": "54092-476-08",
          "description": "3 CARTON in 1 CARTON (54092-476-08)  / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
          "marketing_start_date": "20070116",
          "sample": false
        },
        {
          "package_ndc": "54092-476-12",
          "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12)",
          "marketing_start_date": "20070116",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Takeda Pharmaceuticals America, Inc."
        ],
        "rxcui": [
          "686429",
          "686433"
        ],
        "spl_set_id": [
          "3098a080-be86-4265-9818-7fc4beab77b7"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175781",
          "M0000971"
        ],
        "pharm_class_epc": [
          "Aminosalicylate [EPC]"
        ],
        "pharm_class_cs": [
          "Aminosalicylic Acids [CS]"
        ],
        "unii": [
          "4Q81I59GXC"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "TABLET, DELAYED RELEASE",
      "spl_id": "405a190f-df13-4578-a988-5b291b284f21",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20070116",
      "product_id": "54092-476_405a190f-df13-4578-a988-5b291b284f21",
      "application_number": "NDA022000",
      "brand_name_base": "Lialda",
      "pharm_class": [
        "Aminosalicylate [EPC]",
        "Aminosalicylic Acids [CS]"
      ]
    }
  ]
}