{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0054-0079",
      "generic_name": "Balsalazide Disodium",
      "labeler_name": "Hikma Pharmaceuticals USA Inc.",
      "brand_name": "Balsalazide Disodium",
      "active_ingredients": [
        {
          "name": "BALSALAZIDE DISODIUM",
          "strength": "750 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0054-0079-28",
          "description": "280 CAPSULE in 1 BOTTLE (0054-0079-28)",
          "marketing_start_date": "20071228",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "rxcui": [
          "885857"
        ],
        "spl_set_id": [
          "a0498308-14b2-4456-8e13-795f6fc8ea30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1XL6BJI034"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "CAPSULE",
      "spl_id": "6f5a92d7-1828-44ea-8265-0ed1b3bef16c",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20071228",
      "product_id": "0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16c",
      "application_number": "ANDA077806",
      "brand_name_base": "Balsalazide Disodium",
      "pharm_class": [
        "Aminosalicylate [EPC]",
        "Aminosalicylic Acids [CS]"
      ]
    }
  ]
}