Quick answers
- What is Oxymorphone hydrochloride used for?
- The FDA-approved label (Oxymorphone Hydrochloride, Aurolife Pharma, LLC, June 29, 2026) says: “Oxymorphone hydrochloride tablets is indicated for the management of acute 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 […], reserve opioid analgesics, including oxymorphone hydrochloride …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oxymorphone hydrochloride have a boxed warning?
- Yes. The FDA label for Oxymorphone Hydrochloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Oxymorphone hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oxymorphone hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Oxymorphone hydrochloride?
- 9 companies list prescription products of Oxymorphone hydrochloride in the FDA NDC Directory, including Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York LLC and XLCare Pharmaceuticals, Inc..
What Oxymorphone hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Oxymorphone hydrochloride tablets is indicated for the management of acute 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 […], reserve opioid analgesics, including oxymorphone hydrochloride …
— FDA label: Oxymorphone Hydrochloride, Aurolife Pharma, LLC, effective June 29, 2026. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated, extended release · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 27 in the FDA NDC Directory |
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.
- Amneal Pharmaceuticals LLC7 products
- Amneal Pharmaceuticals of New York LLC7 products
- XLCare Pharmaceuticals, Inc.2 products
- KVK-Tech, Inc.2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Aurolife Pharma, LLC2 products
- Camber Pharmaceuticals, Inc.2 products
- Epic Pharma, LLC2 products
- Bryant Ranch Prepack1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (6)
- ANDA079087Impax Labs · June 14, 2010
- ANDA090964Hikma · September 27, 2010
- ANDA203601Avanthi Inc · January 30, 2013
- ANDA201187Epic Pharma LLC · December 15, 2014
- ANDA204459Aurolife Pharma LLC · April 26, 2016
- ANDA210175Ascent Pharms Inc · February 2, 2018
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) — Oxymorphone Hydrochloride, Aurolife Pharma, LLC, effective June 29, 2026; 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 →