Xcopri

Orange BookUNIISPLATC N03AX25

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

Identification

ManufacturerSK Life Science, Inc.

CountryUS (United States)

ATC codeN03AX25

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7169920414
14 BLISTER PACK in 1 CARTON (71699-204-14) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

P85X70RZWS

CENOBAMATE

RxCUI 2265690

Orange Book

N212839

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P85X70RZWS",
    "rxcui": "2265690",
    "inchikey": "GFHAXPJGXSQLPT-VIFPVBQESA-N",
    "display_name": "CENOBAMATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "71699-204_8e4ae306-0c50-4fe9-92fd-f79be8299f4e",
  "productndc": "71699-204",
  "dosage_form": "TABLET",
  "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": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CENOBAMATE",
  "proprietary_name": "Xcopri",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA212839",
  "marketing_category": "NDA",
  "nonproprietary_name": "cenobamate",
  "start_marketing_date": "20260201",
  "active_numerator_strength": "12.5"
}

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