FDA label
What is Xtampza used for?
Xtampza 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: “XTAMPZA ER 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.”
Run it in Rivvi
Which 2027 plans near you dropped or restricted Xtampza?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Xtampza, capsule, extended release
Indications and Usage, quoted from the label by Collegium Pharmaceutical, Inc. (NDA208090). Cross-references to other label sections are left out.
XTAMPZA ER 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.
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 XTAMPZA ER, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- XTAMPZA ER is not indicated as an as-needed (prn) analgesic.
Source: DailyMed label, set id b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c, version 11, effective December 30, 2025. NDC 24510-110, one of 5 listings for this product.
Questions
What is Xtampza used for?
The FDA label says: “XTAMPZA ER 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.”
What drug class is Xtampza?
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.
More on Xtampza
- Is Xtampza a controlled substance?Schedule II
- 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 RoxicodoneFDA Orange Book
- Generic for OxaydoFDA Orange Book
- Generic for RoxyBondFDA Orange Book
- Opioid Agonists listFDA drug class
- Xtampza Medicare Part D coverageBy plan and state
- NDC 24510-110Xtampza NDC record
- NDC 24510-115Xtampza NDC record
- NDC 24510-120Xtampza NDC record
- Schedule II drugs listDEA schedule