SPL Set ID: d288d165-3505-49bb-9b2e-124490d65f49
1 drug(s) with this SPL Set ID
DANZITEN (nilotinib) tablets contain nilotinib, a kinase inhibitor. Nilotinib is present as nilotinib tartrate, with the molecular formula of C 28 H 22 F 3 N 7 O . C 4 H 6 O 6 and a weight of 679.61 g/mol. Nilotinib tartrate is a white to slightly yellowish powder. The solubility of nilotinib tartrate in aqueous solutions decreases with increasing pH. The pK a 1 was determined to be 3.53; pK a 2 was estimated to be 1.55. The chemical name of nilotinib tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide,(2R,3R)-2,3-dihydroxybutanedionate. Its structure is shown below: DANZITEN (nilotinib) tablets contain 71 mg or 95 mg nilotinib, equivalent to 91.14 mg, and 121.95 mg nilotinib tartrate, respectively. The inactive ingredients are: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, iron oxide red (in 71 mg strength tablets), iron oxide yellow (in 95 mg strength tablets), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Danziten structure