TURALIO Capsule Ref.[10160] Active ingredients:

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

Product description

Pexidartinib is a kinase inhibitor. The chemical name of pexidartinib hydrochloride is 5-[(5-Chloro-1H-pyrrolo[2,3-b]pyridin-3-yl)methyl]N{[6-(trifluoromethyl)pyridin-3-yl]methyl}pyridin-2-amine monohydrochloride. Pexidartinib hydrochloride is an off-white to white solid. The molecular formula for pexidartinib hydrochloride is C20H15ClF3N5∙HCl. The molecular weight is 454.28 for the hydrochloride salt and 417.81 for the free base.

The chemical structure is:

The solubility of pexidartinib hydrochloride in aqueous solutions decreases with increasing pH. The pKa1 and pKa2 were determined to be 2.6 and 5.4 respectively for the conjugate acids. Pexidartinib hydrochloride is soluble in methanol, slightly soluble in water and ethanol, and practically insoluble in heptane.

TURALIO (pexidartinib) capsules are for oral use. Each capsule contains 200 mg pexidartinib which is equivalent to 217.5 mg pexidartinib hydrochloride. The capsule contains the following inactive ingredients: poloxamer 407, mannitol, crospovidone, and magnesium stearate. The hypromellose capsule shell contains hypromellose, titanium dioxide, black iron oxide and yellow iron oxide.

Dosage Forms and Strengths

Capsules: 200 mg, size 0 with white opaque body and dark green opaque cap with white print "T10"

How Supplied

TURALIO 200 mg capsules are supplied as size 0 with white opaque body and dark green opaque cap with white print “T10”, available in:

28 count bottle NDC#: 65597-402-28
120 count bottle NDC#: 65597-402-20

Drugs

Drug Countries
TURALIO United States

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