oxycodone hydrochloride

FDA Drug Profile — OXYCODONE HYDROCHLORIDE, oxycodone hydrochloride, OxyContin, Roxicodone

Drug Details

Generic Name
oxycodone hydrochloride
Brand Names
OXYCODONE HYDROCHLORIDE, oxycodone hydrochloride, OxyContin, Roxicodone
Application Number
ANDA208593
Sponsor
KVK-Tech, Inc.
NDC Codes
17
Dosage Forms
SOLUTION, TABLET, TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
OXYCODONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Oxycodone Hydrochloride Capsules are an opioid agonist indicated in adults 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, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including Oxycodone Hydrochloride Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxycodone Hydrochloride Capsules are an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Oxycodone Hydrochloride Capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 )