XCOPRI TITRATION PACK 50 mg, 100 mg by PCI Pharma Services Canada, Inc.

XCOPRI TITRATION PACK 50 mg, 100 mg by

Drug Labeling and Warnings

XCOPRI TITRATION PACK 50 mg, 100 mg by is a Prescription medication manufactured, distributed, or labeled by PCI Pharma Services Canada, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

XCOPRI TITRATION PACK 50 MG, 100 MG- cenobamate tablet, film coated 
XCOPRI TITRATION PACK 12.5 MG, 25 MG- cenobamate tablet, film coated 
XCOPRI TITRATION PACK 150 MG, 200 MG- cenobamate tablet, film coated 
XCOPRI MAINTENANCE PACK 100 MG, 150 MG- cenobamate tablet, film coated 
XCOPRI MAINTENANCE PACK 150 MG, 200 MG- cenobamate tablet, film coated 
PCI Pharma Services Canada, Inc.

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INDICATIONS AND USAGE

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

XCOPRI TITRATION PACK 50 MG, 100 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-204
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	100 mg  in 100

Product Characteristics
Color	brown	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	SK;100
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-204-14	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

XCOPRI TITRATION PACK 12.5 MG, 25 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-202
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	25 mg  in 25

Product Characteristics
Color	brown	Score	score with uneven pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	SK;25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-202-14	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

XCOPRI TITRATION PACK 12.5 MG, 25 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-201
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	12.5 mg  in 12.5

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	SK;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-201-14	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

XCOPRI TITRATION PACK 150 MG, 200 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-205
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	150 mg  in 150

Product Characteristics
Color	orange ((light orange))	Score	score with uneven pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	SK;150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-205-14	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

XCOPRI TITRATION PACK 150 MG, 200 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-206
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	200 mg  in 200

Product Characteristics
Color	orange ((light orange))	Score	score with uneven pieces
Shape	OVAL (Modified Oval)	Size	19mm
Flavor		Imprint Code	SK;200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-206-28	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

XCOPRI MAINTENANCE PACK 100 MG, 150 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-104
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	100 mg  in 100

Product Characteristics
Color	brown	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	SK;100
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-104-56	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

XCOPRI MAINTENANCE PACK 100 MG, 150 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-101
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	150 mg  in 150

Product Characteristics
Color	orange ((light orange))	Score	score with uneven pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	SK;150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-101-56	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

XCOPRI MAINTENANCE PACK 150 MG, 200 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-102
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	200 mg  in 200

Product Characteristics
Color	orange ((light orange))	Score	score with uneven pieces
Shape	OVAL (modified oval)	Size	19mm
Flavor		Imprint Code	SK;200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-102-56	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

XCOPRI MAINTENANCE PACK 150 MG, 200 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-103
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	150 mg  in 150

Product Characteristics
Color	orange ((light orange))	Score	score with uneven pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	SK;150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-103-56	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

XCOPRI TITRATION PACK 50 MG, 100 MG 
cenobamate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83114-203
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENOBAMATE (UNII: P85X70RZWS) (CENOBAMATE - UNII:P85X70RZWS)	CENOBAMATE	50 mg  in 50

Product Characteristics
Color	yellow	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	SK;50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83114-203-14	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/12/2020	03/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA212839	03/12/2020	03/12/2020

Labeler - PCI Pharma Services Canada, Inc. (204123822)

Establishment
Name	Address	ID/FEI	Business Operations
PCI Pharma Services Canada, Inc.		204123822	pack(83114-201, 83114-202, 83114-203, 83114-204, 83114-205, 83114-206, 83114-101, 83114-102, 83114-103, 83114-104) , label(83114-201, 83114-202, 83114-203, 83114-204, 83114-205, 83114-206, 83114-101, 83114-102, 83114-103, 83114-104) , manufacture(83114-201, 83114-202, 83114-203, 83114-204, 83114-205, 83114-206, 83114-101, 83114-102, 83114-103, 83114-104)

Revised: 5/2024

Document Id: 180c2238-f5f5-e191-e063-6394a90a9bca

34391-3

Set id: 0f2c0e91-f75a-5b29-e063-6294a90abf1a

Version: 2

Effective Time: 20240509