ORZEYFUL Tablet Ref.[116888] Active ingredients: Oveporexton

Source: FDA, National Drug Code (US)  Revision Year: 2026 

Product description

ORZEYFUL contains oveporexton, an orexin receptor 2 (OX2R) agonist.

Oveporexton is described chemically as: N-{(2S,3R)-4,4-Difluoro-1-(2-hydroxy-2-methylpropanoyl)-2- [(2,3',5'-trifluoro[1,1'-biphenyl]-3-yl)methyl]pyrrolidin-3-yl}ethanesulfonamide.The molecular formula is: C23H25F5N2O4S and the molecular weight is 520.51. Oveporexton's structural formula is:

Oveporexton is a white to nearly white powder.

ORZEYFUL (oveporexton) tablets for oral administration contains 0.5 mg, 1 mg, or 2 mg of oveporexton. The inactive ingredients are hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate (type A). The tablet coating consists of calcium carbonate, ferric oxide red, ferric oxide yellow, hypromellose 2910, and polyethylene glycol 8000.

Dosage Forms and Strengths

Tablets:

  • 0.5 mg: light orange, round, debossed with " " and "0.5" on one side.
  • 1 mg: orange, round, debossed with " " and "1" on one side.
  • 2 mg: dark red, round, debossed with " " and "2" on one side.
How Supplied

Table 4 displays the strengths and identifying characteristics of ORZEYFUL (oveporexton) tablets.

Table 4. Strengths and Identifying Characteristics of ORZEYFUL (oveporexton) Tablets:

StrengthColor / ShapeMarkingQuantity
in Bottle		NDC Number
0.5 mgLight orange, round
tablet		debossed with
" " and "0.5" on one side		6064764-205-60
1 mgOrange, round tabletdebossed with
" " and "1" on one side		6064764-210-60
2 mgDark red, round tabletdebossed with
" " and "2" on one side		6064764-220-60

Store ORZEYFUL at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Distributed by: Takeda Pharmaceuticals America, Inc., Cambridge, MA 02142

Drugs

Drug Countries
ORZEYFUL United States
 
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