SPL Set ID: 28156b13-0ba9-4dc4-be24-9c3070a7e1cc

Oxycodone hydrochloride tablets USP is an opioid analgesic. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula: The tablets contain the following inactive ingredients: corn starch; lactose monohydrate; microcrystalline cellulose, silicon dioxide, sodium starch glycolate; and stearic acid. T.he 10 mg tablet also contains D&C Red No. 27 aluminum lake. The 15 mg tablet also contains D&C Yellow No. 10 aluminum lake and FD&C Blue No.2 aluminum lake. The20 mg tablet also contains FD&C Blue No. 2 aluminum lake; FD&C Red No. 40 aluminum lake; and FD&C Yellow No.6 aluminum lake. The 30 mg tablet also contains FD&C Blue No.2 aluminum lakeBlue No. 2 (15 mg and 30 mg tablets). The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base. Oxycodone Hydrochloride structural formula