ROZLYTREK Hard capsule Ref.[10280] Active ingredients: Entrectinib

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

Product description

Entrectinib is a kinase inhibitor. The molecular formula for entrectinib is C31H34F2N6O2 and the molecular weight is 560.64 Daltons. The chemical name is N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]4(4-methylpiperazin-1-yl)2(tetrahydro-2H-pyran-4-ylamino) benzamide.

The chemical structure of entrectinib is as follows:

Entrectinib is white to pale pink powder.

ROZLYTREK (entrectinib) capsules for oral use are supplied as printed hard-shell capsules containing 100 mg (yellow opaque HPMC capsule) or 200 mg of entrectinib (orange opaque HPMC capsule). Inactive ingredients are tartaric acid, lactose anhydrous, hypromellose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.

The yellow opaque capsule shell contains hypromellose, titanium dioxide, and yellow iron oxide. The orange opaque capsule shell contains hypromellose, titanium dioxide, and FD&C yellow #6. The printing ink contains shellac, propylene glycol, strong ammonia solution, and FD&C blue #2 aluminum lake.

Dosage Forms and Strengths

Hard capsules:

  • 100 mg: Size 2 yellow opaque body and cap, with “ENT 100” printed in blue ink on body.
  • 200 mg: Size 0 orange opaque body and cap, with “ENT 200” printed in blue ink on body.
How Supplied
  • 100 mg hard capsules: Size 2 yellow opaque, with “ENT 100” printed in blue ink; available in:

HDPE bottles of 30 capsules: NDC 50242-091-30

  • 200 mg hard capsules: Size 0 orange opaque, with “ENT 200” printed in blue ink; available in:

HDPE bottles of 90 capsules: NDC 50242-094-90

Drugs

Drug Countries
ROZLYTREK Austria, Australia, Canada, Ecuador, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States
 
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