SPL Set ID: a591e33a-52f0-41c8-a00b-4a1afcc3dc4c

1 drug(s) with this SPL Set ID

Open DailyMed details

Bupropion Hydrochloride SR BUPROPION HYDROCHLORIDE
ACTAVIS PHARMA, INC. FDA Rx Only

Bupropion hydrochloride extended-release tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion hydrochloride extended-release tablets, USP (SR) are chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN ® [bupropion hydrochloride] tablets and WELLBUTRIN SR ® [bupropion hydrochloride] sustained-release tablets), bupropion hydrochloride extended-release tablets, USP (SR) are also 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 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 (SR) are supplied for oral administration as 150 mg white to off-white, film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and stearic acid. The film-coating contains hydroxypropyl cellulose, lactose monohydrate, polyethylene glycol, and titanium dioxide. bupropion hydrochloride chemical structure

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