SPL Set ID: 5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f

Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1­-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3- biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C 25 H 22 N 4 O 4 • 2(C 2 H 7 NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula: Eltrombopag olamine is sparingly soluble in dimethyl sulphoxide. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone K 30, and sodium starch glycolate. Coating: 12.5 mg tablets: Hypromellose, titanium dioxide and polyethylene glycol. 25 mg tablets: Hypromellose, polyethylene glycol, titanium dioxide, iron oxide yellow and iron oxide red. 50 mg tablets: Hypromellose, polyethylene glycol, titanium dioxide, fd&c blue #2 and iron oxide yellow. 75 mg tablets: Hypromellose, polyethylene glycol, titanium dioxide, iron oxide black, iron oxide red and iron oxide yellow. eltrombopag-tabs-structure