WELLBUTRIN XL Extended-release tablet Ref.[10622] Active ingredients: Bupropion

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

Product description

Wellbutrin XL (bupropion hydrochloride), 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[(1,1-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 XL tablets are supplied for oral administration as 150 mg and 300 mg creamy-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ethylcellulose, glyceryl behenate, methacrylic acid copolymer dispersion, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, and triethyl citrate. The tablets are printed with edible black ink.

The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces.

Dosage Forms and Strengths

Wellbutrin XL extended-release tablets, 150 mg of bupropion hydrochloride, are creamy-white to pale yellow, round tablets printed with “Wellbutrin XL 150”.

Wellbutrin XL extended-release tablets, 300 mg of bupropion hydrochloride, are creamy-white to pale yellow, round tablets printed with “Wellbutrin XL 300”.

How Supplied

Wellbutrin XL extended-release tablets are supplied as:

NDCStrengthQuantityDescription
0187‑0730‑30 150 mg bottle of 30 tablets Creamy white to pale yellow round tablets imprinted with “Wellbutrin XL 150” in black ink on one side and the other side is plain.
0187‑0730‑90 150 mg bottle of 90 tablets Creamy white to pale yellow round tablets imprinted with “Wellbutrin XL 150” in black ink on one side and the other side is plain.
0187‑0731‑30 300 mg bottle of 30 tablets Creamy white to pale yellow round tablets imprinted with “Wellbutrin XL 300” in black ink on one side and the other side is plain.

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc., Steinbach, MB R5G 1Z7, Canada

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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