Hydrocodone

What is hydrocodone?

Hydrocodone is the most frequently prescribed opioid in the U.S. and is associated with more drug abuse and diversion than any other legal or illicit opioid. Hydrocodone has a chemical structure related to codeine and morphine and is prescribed for the treatment of moderate to severe pain and to relieve cough. There are numerous hydrocodone products on the market. The most frequently prescribed combinations are hydrocodone and acetaminophen as Vicodin, Lorcet, and Lortab; as combination products with aspirin as Lortab ASA; with ibuprofen as Vicoprofen; and with antihistamines as Hycomine.

ROXICODONE®

(oxycodone hydrochloride) Tablets USP

DESCRIPTION

ROXICODONE® (oxycodone hydrochloride tablets USP) is an opioid analgesic.

Each tablet for oral administration contains 5 mg, 15 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 5 mg ROXICODONE® tablet contains inactive ingredients: microcrystalline cellulose and stearic acid. The 15 mg and 30 mg tablets contain the following inactive ingredients: microcrystalline cellulose; sodium starch glycolate; corn starch; lactose; stearic acid; D&C Yellow No. 10 (15 mg tablet); and FD&C Blue No. 2 (15 mg and 30 mg tablets).

The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.

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