REXULTI Tablet Ref.[11112] Active ingredients: Brexpiprazole

Source: FDA, National Drug Code (US) Revision Year: 2021

Product description

Brexpiprazole, an atypical antipsychotic, is available as REXULTI (brexpiprazole) tablets. Brexpiprazole is 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The empirical formula is C₂₅H₂₇N₃O₂S and its molecular weight is 433.57.

The chemical structure is:

REXULTI tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, and talc. Colorants include titanium dioxide, iron oxide and ferrosferric oxide.

Dosage Forms and Strengths

REXULTI tablets are available in 6 strengths (see Table 2).

Table 2. REXULTI Tablet Strengths and Identifying Features:

Tablet Strength	Tablet Color/Shape	Tablet Markings
0.25 mg	light brown round; shallow convex; bevel-edged	“BRX” and “0.25”
0.5 mg	light orange round; shallow convex; bevel-edged	“BRX” and “0.5”
1 mg	light yellow round; shallow convex; bevel-edged	“BRX” and “1”
2 mg	light green round; shallow convex; bevel-edged	“BRX” and “2”
3 mg	light purple round; shallow convex; bevel-edged	“BRX” and “3”
4 mg	white round; shallow convex; bevel-edged	“BRX” and “4”

How Supplied

REXULTI (brexpiprazole) tablets have markings on one side and are available in the following strengths and package configurations (see Table 13):

Table 13. Package Configuration for REXULTI Tablets:

Tablet Strength	Tablet Color/Shape	Tablet Markings	Pack Size	NDC Code
0.25 mg	light brown round; shallow convex; bevel-edged	“BRX” and “0.25”	Bottle of 30	59148-035-13
0.5 mg	light orange round; shallow convex; bevel-edged	“BRX” and “0.5”	Bottle of 30	59148-036-13
1 mg	light yellow round; shallow convex; bevel-edged	“BRX” and “1”	Bottle of 30	59148-037-13
2 mg	light green round; shallow convex; bevel-edged	“BRX” and “2”	Bottle of 30	59148-038-13
3 mg	light purple round; shallow convex; bevel-edged	“BRX” and “3”	Bottle of 30	59148-039-13
4 mg	white round; shallow convex; bevel-edged	“BRX” and “4”	Bottle of 30	59148-040-13

Manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo 101-8535, Japan

Distributed and Marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA

Marketed by Lundbeck, Deerfield, IL 60015 USA

Drugs

Drug	Countries
REXULTI	Australia, Brazil, Canada, Ecuador, Hong Kong, Israel, Japan, Singapore, Turkey, United States, South Africa

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