Lumryz

{
  "unii": {
    "unii": "7G33012534",
    "rxcui": "9899",
    "inchikey": "XYGBKMMCQDZQOZ-UHFFFAOYSA-M",
    "display_name": "SODIUM OXYBATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "10e5e40c-52f3-4c73-8a34-2c29c690a934": {
      "match": "brand_token",
      "title": "LUMRYZ (SODIUM OXYBATE) FOR SUSPENSION, EXTENDED RELEASE LUMRYZ (SODIUM OXYBATE) KIT [AVADEL CNS PHARMACEUTICALS, LLC]",
      "spl_version": "10",
      "published_date": "2025-12-10"
    }
  },
  "productid": "13551-001_bd9a6c48-be50-44e5-8cbb-87cbaafe936d",
  "productndc": "13551-001",
  "dosage_form": "FOR SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "214755",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4.5GM/PACKET",
        "product_no": "001",
        "approval_date": "May 1, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "6GM/PACKET",
        "product_no": "002",
        "approval_date": "May 1, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7.5GM/PACKET",
        "product_no": "003",
        "approval_date": "May 1, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "9GM/PACKET",
        "product_no": "004",
        "approval_date": "May 1, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM OXYBATE",
  "shortage_reason": "Sodium Bicarbonate Injection",
  "shortage_status": "current",
  "proprietary_name": "Lumryz",
  "active_ingred_unit": "g/1",
  "application_number": "NDA214755",
  "marketing_category": "NDA",
  "nonproprietary_name": "sodium oxybate",
  "start_marketing_date": "20230501",
  "active_numerator_strength": "4.5"
}