FDA label
What is Roxicodone used for?
Roxicodone 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: “ROXICODONE is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
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Roxicodone, tablet
Indications and Usage, quoted from the label by SpecGx LLC (NDA021011). Cross-references to other label sections are left out.
ROXICODONE 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ROXICODONE for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 5a8157d3-ba20-4abf-b0d4-6ad141b31d63, version 30, effective April 24, 2026. NDC 23635-581, one of 2 listings for this product.
Questions
What is Roxicodone used for?
The FDA label says: “ROXICODONE is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
What drug class is Roxicodone?
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 RoxicodoneFDA Orange Book
- What is Oxycodone used for?FDA label uses
- Is Oxycodone a controlled substance?Schedule II
- Generic for Xtampza ERFDA Orange Book
- Generic for OxyContinFDA Orange Book
- Generic for OxaydoFDA Orange Book
- Generic for RoxyBondFDA Orange Book
- Opioid Agonists listFDA drug class
- Roxicodone Medicare Part D coverageBy plan and state
- NDC 23635-581Roxicodone NDC record
- NDC 23635-582Roxicodone NDC record
- Schedule II drugs listDEA schedule