Source: FDA, National Drug Code (US) Revision Year: 2022
Oxycodone hydrochloride oral solution is an opioid agonist, available as solution in 5 mg/5 mL (1 mg/mL) strength for oral administration.
Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17- methylmorphinan-6one hydrochloride and has the following structural formula:
C18H21NO4•HCl MW 351.82
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).
Oxycodone hydrochloride is a clear red solution with raspberry odor.
Oxycodone hydrochloride oral solution, 5 mg per 5 mL contains equivalent of 4.5 mg of oxycodone free base per 5 mL’s and contains the following inactive ingredients: citric acid anhydrous USP, FD&C Red No. 40, glycerin USP, poloxamer 188 NF, purified water USP, raspberry flavor, sodium benzoate NF, sorbitol solution USP.
| Dosage Forms and Strengths |
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Oxycodone hydrochloride oral solution, USP 5 mg per 5 mL (1 mg /mL). |
| How Supplied |
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Oxycodone Hydrochloride Oral Solution, USP, 5 mg per 5 mL (1 mg/mL) is available as follows: 500 mL bottle packaged with calibrated measuring cup 5 mL unit dose in trays of ten cups, case of 40. Dispense in a tight, light-resistant container as defined in the USP/NF. Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 |
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