Source: FDA, National Drug Code (US) Revision Year: 2023
Belumosudil is a kinase inhibitor. The active pharmaceutical ingredient is belumosudil mesylate with the molecular formula C27H28N6O5S and the molecular weight is 548.62 g/mol. The chemical name for belumosudil mesylate is 2-{3-[4-(1H-indazol-5-ylamino)-2-quinazolinyl]phenoxy}N(propan-2-yl) acetamide methanesulfonate (1:1).
The chemical structure is as follows:
Belumosudil mesylate is a yellow powder that is practically insoluble in water, slightly soluble in methanol and DMF and soluble in DMSO.
REZUROCK tablets are for oral administration. Each tablet contains 200 mg of the free base equivalent to 242.5 mg of belumosudil mesylate. The tablet also contains the following inactive ingredients: microcrystalline cellulose, hypromellose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.
The tablet film consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and yellow iron oxide.
| Dosage Forms and Strengths |
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Each 200 mg belumosudil tablet is a pale yellow film-coated oblong tablet debossed with “KDM” on one side and “200” on the other side. |
| How Supplied |
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REZUROCK 200 mg tablets are supplied as pale yellow film-coated oblong tablets containing 200 mg of belumosudil (equivalent to 242.5 mg belumosudil mesylate). Each tablet is debossed with “KDM” on one side and “200” on the other side and is packaged as follows:
Distributed and marketed by: Kadmon Pharmaceuticals, LLC, Bridgewater, NJ 08807 |
| Drug | Countries | |
|---|---|---|
| REZUROCK | Canada, United States |
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