Xcopri

Orange BookSPL

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

Identification

ManufacturerSK Life Science, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7169920328
1 KIT in 1 CARTON (71699-203-28) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

Orange Book

N212839

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "565c2126-57ae-4e29-b443-723bbe7e2072": {
      "match": "brand_token",
      "title": "XCOPRI TITRATION PACK (CENOBAMATE) KIT XCOPRI (CENOBAMATE) TABLET, FILM COATED XCOPRI MAINTENANCE PACK (CENOBAMATE) KIT XCOPRI (CENOBAMATE) TABLET [SK LIFE SCIENCE, INC.]",
      "spl_version": "43",
      "published_date": "2026-02-02"
    }
  },
  "productid": "71699-203_8e4ae306-0c50-4fe9-92fd-f79be8299f4e",
  "productndc": "71699-203",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "212839",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Mar 10, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Mar 10, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Mar 10, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Mar 10, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Mar 10, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "006",
        "approval_date": "Mar 10, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Xcopri",
  "active_ingred_unit": null,
  "application_number": "NDA212839",
  "marketing_category": "NDA",
  "nonproprietary_name": "cenobamate",
  "start_marketing_date": "20200312",
  "active_numerator_strength": null
}

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