FDA label
What is OxyContin used for?
OxyContin contains oxycodone. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “OXYCONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, in: Adults; and; Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equ...”
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OxyContin, tablet, film coated, extended release
Indications and Usage, quoted from the label by Knoa Pharma LLC (NDA022272). Cross-references to other label sections are left out.
OXYCONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, in:
- Adults; and
- Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.
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 OXYCONTIN, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- OXYCONTIN is not indicated as an as-needed (prn) analgesic.
Source: DailyMed label, set id bfdfe235-d717-4855-a3c8-a13d26dadede, version 44, effective June 24, 2026. NDC 59011-410, one of 7 listings for this product.
Questions
What is OxyContin used for?
The FDA label says: “OXYCONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, in: Adults; and; Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equ...”
What drug class is OxyContin?
FDA lists oxycodone in the Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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- Generic for OxyContinFDA Orange Book
- What is Oxycodone used for?FDA label uses
- Is Oxycodone a controlled substance?Schedule II
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- Generic for RoxyBondFDA Orange Book
- Opioid Agonists listFDA drug class
- OxyContin Medicare Part D coverageBy plan and state
- NDC 59011-410OxyContin NDC record
- NDC 59011-415OxyContin NDC record
- NDC 59011-420OxyContin NDC record
- Schedule II drugs listDEA schedule