Quick answers
- What is Oxycodone used for?
- The FDA-approved label (Xtampza ER, Collegium Pharmaceutical, Inc., December 30, 2025) 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oxycodone have a boxed warning?
- Yes. The FDA label for Xtampza ER has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Oxycodone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oxycodone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Oxycodone?
- 1 company lists prescription products of Oxycodone in the FDA NDC Directory, including Collegium Pharmaceutical, Inc..
What Oxycodone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Xtampza ER, Collegium Pharmaceutical, Inc., effective December 30, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER
. Read it on the full label →
Forms and how it is given
| Dosage forms | Capsule, extended release |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Xtampza ER |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Collegium Pharmaceutical, Inc.5 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208090 XTAMPZA ER | Collegium Pharm Inc | April 26, 2016 | 13, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xtampza ER, Collegium Pharmaceutical, Inc., effective December 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →