TRINTELLIX Film-coated tablet Ref.[11067] Active ingredients: Vortioxetine

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

Product description

TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18H22N2S, HBr with a molecular weight of 379.36 g/mol.

The structural formula is:

Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water.

Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).

Dosage Forms and Strengths

TRINTELLIX is available as immediate-release, film-coated tablets in the following strengths:

  • 5 mg: pink, almond shaped biconvex film coated tablet, debossed with “5” on one side and “TL” on the other side.
  • 10 mg: yellow, almond shaped biconvex film coated tablet, debossed with “10” on one side and “TL” on the other side.
  • 20 mg: red, almond shaped biconvex film coated tablet, debossed with “20” on one side and “TL” on the other side.
How Supplied

TRINTELLIX tablets are available as follows:

Features Strengths
 5 mg 10 mg 20 mg
Color pink yellow red
Debossment “5” on one side of tablet “10” on one side of tablet “20” on one side of tablet
“TL” on other side of tablet “TL” on other side of tablet “TL” on other side of tablet
Presentations and NDC Codes
Bottles of 30 64764-720-30 64764-730-30 64764-750-30
Bottles of 90 64764-720-90 64764-730-90 64764-750-90
Bottles of 500 64764-720-77 64764-730-77 64764-750-77

Distributed and marketed by: Takeda Pharmaceuticals America, Inc., Lexington, MA, 02421

Marketed by: Lundbeck, Deerfield, IL 60015

Drugs

Drug Countries
TRINTELLIX Canada, Japan, United States
 
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