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ROXICODONE®: (oxycodone hydrochloride) Tablets USP

DESCRIPTION

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

Each tablet for oral administration contains 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

The 30 mg tablet contain the following inactive ingredients: microcrystalline cellulose; sodium starch glycolate; corn starch; lactose; stearic acid; D&C Yellow No. 10

The Roxicodone 30 mg tablet contain the equivalent of 27.0 mg, of oxycodone free base.

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INDICATIONS

ROXICODONE® tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

HOW SUPPLIED

ROXICODONE (oxycodone hydrochloride tablets USP):
30 mg blue tablets scored (Identified 54 199)
[Embossed 54 199 on one side]

Dispense in a tight, light-resistant container.
Protect from moisture.
Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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