SPL Set ID: c1fa6fce-272b-4497-a958-177f0bafdfc7

Bupropion hydrochloride, USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino] 1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride, USP powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride tablets, USP are supplied for oral administration as 75-mg (yellow) and 100-mg (red) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: 75-mg tablet – microcrystalline cellulose, hydroxypropyl methylcellulose, crospovidone, diluted HCl, colloidal silicon dioxide, stearic acid, magnesium stearate, talc, glycerol triacetate, D&C yellow no. 10 aluminum lake, titanium dioxide and FD&C yellow no. 6; 100-mg tablet – microcrystalline cellulose, hydroxypropyl methylcellulose, crospovidone, diluted HCl, colloidal silicon dioxide, stearic acid, magnesium stearate, glycerol triacetate, talc, titanium dioxide, FD&C Red no. 40 and FD&C yellow no. 6.