SPL Set ID: fddc9630-2f9a-4104-888f-3714587d4fe7
1 drug(s) with this SPL Set ID
Bupropion hydrochloride extended-release tablets, USP (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2 g/mol. 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 extended-release tablets, USP (XL) are supplied for oral administration as 150 mg, yellow extended-release tablets. Each tablet contains 150 mg of bupropion hydrochloride, USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film-coating material contains FD&C red #40, FD&C yellow #5, hypromellose type 2910/3 cP, 6 cP and 50 cP, polyethylene glycol, polydextrose, titanium dioxide and triacetin. Bupropion hydrochloride extended-release tablets, USP (XL) meet USP Dissolution Test 6. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Chemical Structure