NERLYNX Film-coated tablet Ref.[10146] Active ingredients: Neratinib

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

Product description

NERLYNX (neratinib) immediate release, film-coated tablets for oral administration contain 40 mg of neratinib, equivalent to 48.31 mg neratinib maleate. Neratinib is a member of the 4-anilino quinolidine class of protein kinase inhibitors. The molecular formula for neratinib maleate is C 30H 29ClN 6O 3â€ĒC 4H 4O 4 and the molecular weight is 673.11 Daltons.

The chemical name is (E)N{4-[3-chloro-4-(pyridin-2-ylmethoxy)anilino]-3-cyano-7-ethoxyquinolin-6-yl}4(dimethylamino)but-2-enamide maleate, and its structural formula is:

Neratinib maleate is an off-white to yellow powder with pKas of 7.65 and 4.66. The solubility of neratinib maleate increases dramatically as neratinib becomes protonated at acidic pH. Neratinib maleate is sparingly soluble at pH 1.2 (32.90 mg/mL) and insoluble at approximate pH 5.0 and above (0.08 mg/mL or less).

Inactive ingredients: Tablet Core: colloidal silicon dioxide, mannitol, microcrystalline cellulose, crospovidone, povidone, magnesium stearate, and purified water. Coating: red film coat: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.

Dosage Forms and Strengths

Tablets: 40 mg neratinib (equivalent to 48.31 mg of neratinib maleate).

Film-coated, red, oval shaped and debossed with ‘W104’ on one side and plain on the other side.

How Supplied

NERLYNX 40 mg film-coated tablets are red, oval shaped and debossed with ‘W104’ on one side and plain on the other side.

NERLYNX is available in:

  • Bottles of 180 tablets: NDC 70437-240-18
  • Bottles of 126 tablets: NDC 70437-240-26

Drugs

Drug Countries
NERLYNX Austria, Canada, Ecuador, Estonia, Finland, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States

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