Oxycodone Hcl

FDA Drug Profile

Drug Details

Generic Name
Oxycodone Hcl
Brand Names
N/A
Application Number
Sponsor
LETCO MEDICAL, LLC
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
OXYCODONE HYDROCHLORIDE

Indications and Usage

Oxycodone hydrochloride is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone hydrochloride should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.