Lumryz

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAvadel CNS Pharmaceuticals, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1355100501
1 KIT in 1 CARTON (13551-005-01) * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET

Annotations

Orange Book

N214755

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "13551-005_bd9a6c48-be50-44e5-8cbb-87cbaafe936d",
  "productndc": "13551-005",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Lumryz",
  "active_ingred_unit": null,
  "application_number": "NDA214755",
  "marketing_category": "NDA",
  "nonproprietary_name": "sodium oxybate",
  "start_marketing_date": "20241007",
  "active_numerator_strength": null
}

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