OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 80 mg CII
DESCRIPTION
Oxycodone Hydrochloride Extended-Release Tablets are an opioid analgesic supplied in 80 mg tablet strength for oral administration. The tablet strength describes the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:
C18H21NO4•HCl M.W. 351.82
The chemical formula is 4,5-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.
Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). Each tablet contains 80 mg of oxycodone hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C blue #2 indigo carmine lake, hypromellose (2208, 100M), iron oxide yellow, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and triacetin.
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