FDA.reportPublic FDA data

XCOPRI TITRATION PACK 50 mg, 100 mg

Manufacturer
PCI Pharma Services Canada, Inc.
Effective date
2024-05-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:03:22

Label at a glance#

ProductXCOPRI TITRATION PACK 50 mg, 100 mg
Active ingredientCENOBAMATE
Label structure12 sections

Indications and uses

XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mg Maintenance250 mg Maintenance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mg Maintenance250 mg Maintenance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

350 mg Maintenance350 mg Maintenance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

350 mg Maintenance350 mg Maintenance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 Titration50 Titration

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mg Titration100 mg Titration

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 mg Titration150 mg Titration

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 mg Titration200 mg Titration

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12.5 mg Titration12.5 mg Titration

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25 mg Titration25 mg Titration

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25 mg Titration25 mg Titration

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83114-20183114-201-14
83114-20283114-202-14
83114-20383114-203-14
83114-20483114-204-14
83114-20583114-205-14
83114-20683114-206-28
83114-10183114-101-56
83114-10283114-102-56
83114-10383114-103-56
83114-10483114-104-56

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CENOBAMATEP85X70RZWSACTIB
CENOBAMATEP85X70RZWSACTIB
CENOBAMATEP85X70RZWSACTIB
CENOBAMATEP85X70RZWSACTIB
CENOBAMATEP85X70RZWSACTIB
CENOBAMATEP85X70RZWSACTIB
CENOBAMATEP85X70RZWSACTIB
CENOBAMATEP85X70RZWSACTIB
CENOBAMATEP85X70RZWSACTIB
CENOBAMATEP85X70RZWSACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
180c2238-f5f5-e191-e063-6394a90a9bca0f2c0e91-f75a-5b29-e063-6294a90abf1a2024-05-09Exact identifier
spl set id: 0f2c0e91-f75a-5b29-e063-6294a90abf1a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.