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DESCRIPTION

BRINTELLIX 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:

BRINTELLIX (vortioxetine) Structural Formula Illustration
Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water.

Each BRINTELLIX tablet contains 6.355 mg, 12.71 mg, 19.065 mg, or 25.42 mg of
vortioxetine HBr equivalent to 5 mg, 10 mg, 15 mg, or 20 mg of vortioxetine,
respectively. The inactive ingredients in BRINTELLIX 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, 15 mg, and 20 mg) and iron oxide yellow (10 mg and 15
mg).
                                                         
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