{
  "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": "42799-709",
      "generic_name": "Miglustat",
      "labeler_name": "Edenbridge Pharmaceuticals LLC.",
      "brand_name": "Yargesa",
      "active_ingredients": [
        {
          "name": "MIGLUSTAT",
          "strength": "100 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "42799-709-15",
          "description": "1 BLISTER PACK in 1 CARTON (42799-709-15)  / 15 CAPSULE in 1 BLISTER PACK",
          "marketing_start_date": "20231031",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Edenbridge Pharmaceuticals LLC."
        ],
        "rxcui": [
          "401938",
          "2642350"
        ],
        "spl_set_id": [
          "2b371dfe-e2b0-47fe-b677-a7bde7149f87"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175783",
          "N0000020019",
          "N0000194077",
          "N0000194078"
        ],
        "pharm_class_epc": [
          "Glucosylceramide Synthase Inhibitor [EPC]",
          "Enzyme Stabilizer [EPC]"
        ],
        "pharm_class_moa": [
          "Glucosylceramide Synthase Inhibitors [MoA]",
          "Enzyme Stabilizers [MoA]"
        ],
        "unii": [
          "ADN3S497AZ"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "CAPSULE",
      "spl_id": "462f6c9d-b8f1-3a76-e063-6294a90a2b50",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20200806",
      "product_id": "42799-709_462f6c9d-b8f1-3a76-e063-6294a90a2b50",
      "application_number": "ANDA209821",
      "brand_name_base": "Yargesa",
      "pharm_class": [
        "Enzyme Stabilizer [EPC]",
        "Enzyme Stabilizers [MoA]",
        "Glucosylceramide Synthase Inhibitor [EPC]",
        "Glucosylceramide Synthase Inhibitors [MoA]"
      ]
    }
  ]
}