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United States · US · US:71699-050_8e4ae306-0c50-4fe9-92fd-f79be8299f4e
Xcopri
Orange BookUNIISPLATC N03AX25
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSK Life Science, Inc.
CountryUS (United States)
ATC codeN03AX25
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11716990503030 TABLET, FILM COATED in 1 BOTTLE (71699-050-30)
- ndc11716990509930 TABLET, FILM COATED in 1 BOTTLE (71699-050-99)
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": "71699-050_8e4ae306-0c50-4fe9-92fd-f79be8299f4e",
"productndc": "71699-050",
"dosage_form": "TABLET, FILM COATED",
"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": "20210430",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX25.
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