SPL Set ID: e54ddb53-542b-4183-8950-5b3947ecead0
1 drug(s) with this SPL Set ID
The chemical name for the active ingredient in nebivolol tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)bis(6-fluorochroman-2-yl)]-2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]nebivolol, respectively. Nebivolol’s molecular formula is (C 22 H 25 F 2 NO 4 •HCl) with the following structural formula: SRRR- or d-nebivolol hydrochloride RSSS- or l-nebivolol hydrochloride The molecular weight is 441.90 g/mol. Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethyl formamide and slightly soluble in methanol. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contains the following inactive ingredients: Croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polysorbate 80, FD&C blue No. 2 (2.5 mg and 20 mg), FD&C yellow No. 6 (5 mg), and FD&C red No. 40 (10 mg). nebivolol-structure-1 nebivolol-structure-2