XCOPRI Film-coated tablet Ref.[10091] Active ingredients: Cenobamate

Source: FDA, National Drug Code (US) Revision Year: 2020

Product description

The chemical name of XCOPRI (cenobamate) is [(1R)1(2-Chlorophenyl)2(tetrazol-2-yl) ethyl] carbamate. Its molecular formula is C₁₀H₁₀ClN₅O₂ and its molecular weight is 267.67 g/mol. The chemical structure is:

XCOPRI is a white to off-white crystalline powder. It is very soluble in aqueous solutions (water 1.7 mg/mL) and has higher solubility in organic solvents like ethanol (209.4 mg/mL).

XCOPRI tablets are for oral administration and contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate and film coating agents specified below:

12.5 mg tablets: Not applicable, since 12.5 mg tablets are uncoated.

25 mg and 100 mg tablets: FD&C Blue# 2/indigo carmine aluminum lake, iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

50 mg tablets: iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

150 mg and 200 mg tablets: iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

Dosage Forms and Strengths

XCOPRI tablets are available in the following strengths, shapes, colors, and tablet markings (Table 2).

Table 2. TRADENAME Tablet Presentations:

Tablet Strength	Tablet Color/Shape	Tablet Markings
12.5 mg	Uncoated round white to off-white tablets	SK on one side and 12 on the other side
25 mg	Film coated round brown tablets	SK on one side and 25 on the other side
50 mg	Film coated round yellow tablets	SK on one side and 50 on the other side
100 mg	Film coated round brown tablets	SK on one side and 100 on the other side
150 mg	Film coated round light orange tablets	SK on one side and 150 on the other side
200 mg	Film coated modified oval light orange tablets	SK on one side and 200 on the other side

How Supplied

XCOPRI tablets are supplied in the following configurations:

Bottles; 30 count:

Strength	NDC Number	Tablet Description (Color, Shape, Markings)
50 mg	71699-050-30	Film coated round yellow tablets with SK on one side and 50 on the other side
100 mg	71699-100-30	Film coated round brown tablets with SK on one side and 100 on the other side
150 mg	71699-150-30	Film coated round light orange tablets with SK on one side and 150 on the other side
200 mg	71699-200-30	Film coated modified oval light orange tablets with SK on one side and 200 on the other side

Titration Blister Packs; 28-Day:

Daily Dose	NDC Number	Supplied As [strength(quantity)]	Tablet Description (Color, Shape, Markings)
12.5 mg per day for 14 days, then 25 mg per day for 14 days	71699-201-28	12.5 mg (14-count)	Uncoated round white to off-white tablets with SK on one side and 12 on the other side
12.5 mg per day for 14 days, then 25 mg per day for 14 days	71699-201-28	25 mg (14-count)	Film coated round brown tablets with SK on one side and 25 on the other side
50 mg per day for 14 days, then 100 mg per day for 14 days	71699-202-28	50 mg (14-count)	Film coated round yellow tablets with SK on one side and 50 on the other side
50 mg per day for 14 days, then 100 mg per day for 14 days	71699-202-28	100 mg (14-count)	Film coated round brown tablets with SK on one side and 100 on the other side
150 mg per day for 14 days, then 200 mg per day for 14 days	71699-203-28	150 mg (14-count)	Film coated round light orange tablets with SK on one side and 150 on the other side
150 mg per day for 14 days, then 200 mg per day for 14 days	71699-203-28	200 mg (14-count)	Film coated modified oval light orange tablets with SK on one side and 200 on the other side

Maintenance Blister Packs; 28-Day:

Daily Dose	NDC Number	Supplied As [strength(quantity)]	Tablet Description (Color, Shape, Markings)
250 mg per day	71699-102-56	50 mg (28-count)	Film coated round yellow tablets with SK on one side and 50 on the other side
250 mg per day	71699-102-56	200 mg (28-count)	Film coated modified oval light orange tablets with SK on one side and 200 on the other side
350 mg per day	71699-103-56	150 mg (28-count)	Film coated round light orange tablets with SK on one side and 150 on the other side
350 mg per day	71699-103-56	200 mg (28-count)	Film coated modified oval light orange tablets with SK on one side and 200 on the other side

Drugs

Drug	Countries
XCOPRI	Canada, Israel, United States

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