DAYVIGO Film-coated tablet Ref.[10116] Active ingredients:

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

Product description

DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)2{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}2(3-fluorophenyl)N(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42.

The structural formula is:

Lemborexant is a white to off-white powder that is practically insoluble in water.

DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate.

In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet.

Dosage Forms and Strengths

DAYVIGO (lemborexant) tablets are available as:

  • 5 mg tablets: pale yellow, round, biconvex, film-coated tablets, and debossed with “5” on one side and “LЄM” on the other side.
  • 10 mg tablets: orange, round, biconvex, film-coated tablets, and debossed with “10” on one side and “LЄM” on the other side.
How Supplied

DAYVIGO tablets are available as:

  • 5 mg, pale yellow, round, biconvex, film-coated tablets, and debossed with “5” on one side and “LЄM” on the other side.

NDC 62856-405-30, bottle of 30 with child-resistant closure
NDC 62856-405-90, bottle of 90 with child-resistant closure

  • 10 mg, orange, round, biconvex, film-coated tablets, and debossed with “10” on one side and “LЄM” on the other side.

NDC 62856-410-30, bottle of 30 with child-resistant closure
NDC 62856-410-90, bottle of 90 with child-resistant closure

Drugs

Drug Countries
DAYVIGO Canada, Hong Kong, Israel, Japan, United States
 
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