TRUQAP Film-coated tablet Ref.[107254] Active ingredients: Capivasertib

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

TRUQAP (capivasertib) is a kinase inhibitor. The molecular formula for capivasertib is C21H25ClN6O2 and the molecular weight is 428.92 g/mol. The chemical name of capivasertib is 4-amino-N-1(7Hpyrrolo[2,3d]pyrimidin-4-yl)-4-piperidinecarboxamide. Capivasertib is a white to off-white powder with pH-dependent solubility. It is freely soluble in water at pH values below 1.2 and practically insoluble at pH values above 6.8.

Capivasertib has the following structural formula:

TRUQAP film-coated tablets are supplied for oral administration with 160 mg or 200 mg capivasertib. The tablets also contain croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, and microcrystalline cellulose. The film coat contains the following inactive ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, medium chain triglycerides, polydextrose, polyethylene glycol 3350, and titanium dioxide.

Dosage Forms and Strengths

Tablets:

  • 160 mg: beige film-coated, round, biconvex tablets debossed with ‘CAV’ above ‘160’ on one side and plain on the reverse.
  • 200 mg: beige film-coated, capsule-shaped, biconvex tablets debossed with ‘CAV 200’ on one side and plain on the reverse.
How Supplied

Table 8. TRUQAP 160 mg and 200 mg Tablets:

StrengthDescriptionTablets per Bottle NDC Number
TRUQAP 160 mg Beige film-coated,
round, biconvex
tablets debossed with
‘CAV’ above ‘160’ on
one side and plain on
the reverse supplied
in HDPE bottle with
child-resistant
closure.		64 0310-9500-01
TRUQAP 200 mg Beige film-coated,
capsule-shaped,
biconvex, tablets
debossed with
‘CAV 200’ on one
side and plain on the
reverse supplied in
HDPE bottle with
child-resistant
closure. 		64 0310-9501-01

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Drugs

Drug Countries
TRUQAP Austria, Estonia, France, Lithuania, Romania, United Kingdom, United States
 
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