WELLBUTRIN SR Sustained‑release tablet Ref.[10620] Active ingredients: Bupropion

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

WELLBUTRIN SR (bupropion hydrochloride), 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 C13H18ClNO•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:

WELLBUTRIN SR is supplied for oral administration as 100‑mg (blue), 150‑mg (purple), and 200‑mg (light pink), film‑coated, sustained‑release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: carnauba wax, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide and is printed with edible black ink. In addition, the 100‑mg tablet contains FD&C Blue No. 1 Lake, the 150‑mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200‑mg tablet contains FD&C Red No. 40 Lake.

Dosage Forms and Strengths
  • 100 mg – blue, round, biconvex, film‑coated, sustained-release tablets printed with “WELLBUTRIN SR 100”.
  • 150 mg – purple, round, biconvex, film‑coated, sustained-release tablets printed with “WELLBUTRIN SR 150”.
  • 200 mg – light pink, round, biconvex, film-coated, sustained-release tablets printed with “WELLBUTRIN SR 200”.
How Supplied

WELLBUTRIN SR sustained‑release tablets, 100 mg of bupropion hydrochloride, are blue, round, biconvex, film‑coated tablets printed with “WELLBUTRIN SR 100” in bottles of 60 (NDC 0173-0947-55) tablets.

WELLBUTRIN SR sustained‑release tablets, 150 mg of bupropion hydrochloride, are purple, round, biconvex, film‑coated tablets printed with “WELLBUTRIN SR 150” in bottles of 60 (NDC 0173-0135-55) tablets.

WELLBUTRIN SR sustained-release tablets, 200 mg of bupropion hydrochloride, are light pink, round, biconvex, film-coated tablets printed with “WELLBUTRIN SR 200” in bottles of 60 (NDC 0173-0722-00) tablets.

GlaxoSmithKline, Research Triangle Park, NC 27709

Drugs

Drug Countries
WELLBUTRIN Austria, Brazil, Canada, Cyprus, Germany, Ecuador, Hong Kong, Croatia, Israel, Italy, Malta, Mexico, Netherlands, Poland, Singapore, Turkey, United States, South Africa

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