ALUNBRIG Film-coated tablet Ref.[9973] Active ingredients: Brigatinib

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

Product description

Brigatinib is a kinase inhibitor. The chemical name for brigatinib is 5-chloro-N4-N2{2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}pyrimidine-2,4-diamine. The molecular formula is C29H39ClN7O2P which corresponds to a formula weight of 584.10 g/mol. Brigatinib has no chiral centers. The chemical structure is shown below:

Brigatinib is an off-white to beige/tan solid. The pKas were determined to be: 1.73 ± 0.02 (base), 3.65 ± 0.01 (base), 4.72 ± 0.01 (base), and 8.04 ± 0.01 (base).

ALUNBRIG is supplied for oral use as film-coated tablets containing 180 mg, 90 mg or 30 mg of brigatinib and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate, and hydrophobic colloidal silica. The tablet coating consists of talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide.

Dosage Forms and Strengths
  • 180 mg: oval, white to off-white film-coated tablets with “U13” debossed on one side and plain on the other side
  • 90 mg: oval, white to off-white film-coated tablets with “U7” debossed on one side and plain on the other side
  • 30 mg: round, white to off-white film-coated tablets with “U3” debossed on one side and plain on the other side
How Supplied

180 mg tablets: oval, white to off-white film-coated tablets with “U13” debossed on one side and plain on the other side; available in:

Bottle of 23 tablets NDC 63020-180-23
Bottle of 30 tablets NDC 63020-180-30

90 mg tablets: oval, white to off-white film-coated tablets with “U7” debossed on one side and plain on the other side; available in:

Bottle of 7 tablets NDC 63020-090-07
Bottle of 30 tablets NDC 63020-090-30

30 mg tablets: round, white to off-white film-coated tablets with “U3” debossed on one side and plain on the other side; available in:

Bottle of 30 tablets NDC 63020-113-30

90 mg / 7 count tablets (NDC 63020-090-07) and 180 mg / 23 count tablets (NDC 63020-180-23) are also available in a single carton as a one-month initiation pack:

One carton containing one bottle of 90 mg tablets (7 count) and one bottle of 180 mg tablets (23 count) NDC 63020-198-30

Drugs

Drug Countries
ALUNBRIG Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States
 
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