{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "update_type": "Reverified",
      "initial_posting_date": "01/26/2024",
      "package_ndc": "70726-0303-1",
      "generic_name": "Riluzole Oral Suspension",
      "contact_info": "610-937-6172",
      "availability": "Unavailable",
      "related_info": "Next release not available at this time; Shortage per Manufacturer: Product manufacturing interrupted due to testing",
      "openfda": {
        "application_number": [
          "NDA209080"
        ],
        "brand_name": [
          "TIGLUTIK"
        ],
        "generic_name": [
          "RILUZOLE"
        ],
        "manufacturer_name": [
          "EDW PHARMA, INC"
        ],
        "product_ndc": [
          "70726-0303"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RILUZOLE"
        ],
        "rxcui": [
          "2058147",
          "2059266"
        ],
        "spl_id": [
          "57997dd0-4d88-c2e5-e063-6394a90ae8ae"
        ],
        "spl_set_id": [
          "75d68f19-4208-109e-e053-2991aa0ac857"
        ],
        "package_ndc": [
          "70726-0303-2",
          "70726-0303-1"
        ],
        "nui": [
          "N0000175740",
          "M0483511"
        ],
        "pharm_class_epc": [
          "Benzothiazole [EPC]"
        ],
        "pharm_class_cs": [
          "Benzothiazoles [CS]"
        ],
        "unii": [
          "7LJ087RS6F"
        ]
      },
      "update_date": "08/17/2026",
      "therapeutic_category": [
        "Neurology"
      ],
      "dosage_form": "Oral Suspension",
      "presentation": "Tiglutik, Oral Suspension, 50 mg/10 mL (NDC 70726-0303-1)",
      "company_name": "EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.)",
      "shortage_reason": "Requirements related to complying with good manufacturing practices",
      "status": "Current"
    }
  ]
}