CALQUENCE Capsule Ref.[10764] Active ingredients: Acalabrutinib

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

CALQUENCE (acalabrutinib) is an inhibitor of Bruton tyrosine kinase (BTK). The molecular formula for acalabrutinib is C26H23N7O2, and the molecular weight is 465.51. The chemical name is 4-{8-amino-3-[(2S)1(but-2-ynoyl)pyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl)}N(pyridine-2-yl)benzamide.

The chemical structure of acalabrutinib is shown below:

Acalabrutinib is a white to yellow powder with pH-dependent solubility. It is freely soluble in water at pH values below 3 and practically insoluble at pH values above 6.

CALQUENCE capsules for oral administration contains 100 mg acalabrutinib and the following inactive ingredients: silicified microcrystalline cellulose, partially pregelatinized starch, magnesium stearate, and sodium starch glycolate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide, FD&C Blue 2 and is imprinted with edible black ink.

Dosage Forms and Strengths

100 mg capsules.

How Supplied
Pack SizeContentsNDC Number
60-count bottle Bottle containing 60 capsules100 mg, hard gelatin capsules with yellow body and blue cap, marked in black ink with ‘ACA 100 mg’ 0310-0512-60

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Drugs

Drug Countries
CALQUENCE Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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