CONTRAVE prolonged release tri-layer tablets, 8 mg/90 mg, are blue, round, bi-convex, film-coated, and debossed with "NB-890" on one side.
Active ingredient: naltrexone hydrochloride 8mg and bupropion hydrochloride 90mg.
CONTRAVE prolonged release tablets contain naltrexone hydrochloride and bupropion hydrochloride.
Naltrexone hydrochloride, USP, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone.
Naltrexone hydrochloride has the chemical name of morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, hydrochloride, (5α)-. The empirical formula is C20H23NO4·HCl and the molecular weight is 377.86.
Naltrexone hydrochloride is a white to yellowish, crystalline compound. It is soluble in water to the extent of about 100 mg/mL.
Bupropion hydrochloride is an antidepressant of the aminoketone class. Bupropion hydrochloride closely resembles the structure of diethylpropion. It is designated as (±)-1-(3 chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propranone hydrochloride. It is related to phenylethylamines. The empirical formula is C13H18ClNO·HCl and the molecular weight is 276.2.
Bupropion hydrochloride powder is white, crystalline, and highly soluble in water.
CONTRAVE is available for oral administration as a round, bi-convex, film-coated, extended-release tablet. Each tablet has a trilayer core composed of two drug layers, containing the drug and excipients, separated by a more rapidly dissolving inert layer. Each tablet contains 8 mg of naltrexone hydrochloride and 90 mg of bupropion hydrochloride. Tablets are blue and are debossed with NB-890 on one side.
Excipients/Inactive Ingredients: microcrystalline cellulose, hydroxypropyl cellulose, lactose anhydrous, L-cysteine hydrochloride, crospovidone, magnesium stearate, hypromellose, edetate disodium, lactose monohydrate, colloidal silicon dioxide, Opadry II Blue, macrogol, polyvinyl alcohol, talc, titanium dioxide and FD&C Blue #2 aluminium lake.
                                
                            
                
                                    
                                            
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