Quick answers
- What is Oxycodone hydrochloride used for?
- The FDA-approved label (Roxicodone, SpecGx LLC, April 24, 2026) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oxycodone hydrochloride have a boxed warning?
- Yes. The FDA label for Roxicodone has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXICODONE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Oxycodone hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oxycodone hydrochloride been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started January 14, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Oxycodone hydrochloride?
- 34 companies list prescription products of Oxycodone hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc. and SpecGx LLC.
What Oxycodone hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Roxicodone, SpecGx LLC, effective April 24, 2026. Read the full label on DailyMed →
The FDA has 86 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. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXICODONE
. Read it on the full label →
83 of 86 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| oxycodone hydrochloride 10 mg tablet | Generic | $0.1563 per tablet |
| oxycodone hydrochloride 10 mg tablet, film coated, extended release | Brand: OxyContin | $5.87 per tablet |
| oxycodone hydrochloride 100 mg/5 mL solution | Generic | $2.26 per mL |
| oxycodone hydrochloride 15 mg tablet | Generic | $0.1993 per tablet |
| oxycodone hydrochloride 15 mg tablet | Brand: Roxicodone | $5.47 per tablet |
| oxycodone hydrochloride 15 mg tablet, film coated, extended release | Brand: OxyContin | $8.66 per tablet |
| oxycodone hydrochloride 20 mg tablet | Generic | $0.2582 per tablet |
| oxycodone hydrochloride 20 mg tablet, film coated, extended release | Brand: OxyContin | $10.95 per tablet |
| oxycodone hydrochloride 20 mg/mL solution | Generic | $2.26 per mL |
| oxycodone hydrochloride 30 mg tablet | Generic | $0.3612 per tablet |
| oxycodone hydrochloride 30 mg tablet | Brand: Roxicodone | $10.70 per tablet |
| oxycodone hydrochloride 30 mg tablet, film coated, extended release | Brand: OxyContin | $15.22 per tablet |
| oxycodone hydrochloride 40 mg tablet, film coated, extended release | Brand: OxyContin | $18.77 per tablet |
| oxycodone hydrochloride 5 mg capsule | Generic | $0.3816 per capsule |
| oxycodone hydrochloride 5 mg tablet | Generic | $0.0924 per tablet |
| oxycodone hydrochloride 5 mg/5 mL solution | Generic | $0.0496–$0.0716 per mL 6 packages, lowest to highest |
| oxycodone hydrochloride 60 mg tablet, film coated, extended release | Brand: OxyContin | $26.53 per tablet |
| oxycodone hydrochloride 80 mg tablet, film coated, extended release | Brand: OxyContin | $32.64 per tablet |
NADAC list of November 4, 2026; these prices took effect between September 23, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Bryant Ranch Prepack24 products
- Asclemed USA, Inc.13 products
- SpecGx LLC9 products
- KVK-Tech, Inc.8 products
- Knoa Pharma LLC7 products
- Direct_Rx7 products
- St. Mary's Medical Park Pharmacy6 products
- Lupin Pharmaceuticals, Inc.6 products
- Epic Pharma, LLC5 products
- Aurolife Pharma, LLC5 products
- Rhodes Pharmaceuticals LLC5 products
- Strides Pharma Science Limited5 products
- Camber Pharmaceuticals, Inc.5 products
- Amneal Pharmaceuticals LLC5 products
- American Health Packaging5 products
- Major Pharmaceuticals4 products
- Protega Pharmaceuticals Inc4 products
- Redpharm Drug4 products
- Alvogen Inc.3 products
- Quality Care Products, LLC3 products
- NuCare Pharmaceuticals, Inc.3 products
- Ascent Pharmaceuticals Inc2 products
- Zyla Life Sciences US LLC2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Eywa Pharma Inc2 products
- ANI Pharmaceuticals, Inc.2 products
- Quagen Pharmaceuticals LLC2 products
- XLCare Pharmaceuticals, Inc.2 products
- Hikma Pharmceuticals USA Inc.1 product
- Novel Laboratories, Inc.1 product
- Precision Dose, Inc.1 product
- Genus Lifesciences Inc.1 product
- RedPharm Drug, Inc.1 product
- Amneal Pharmaceuticals of New York LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021011 ROXICODONE | Specgx LLC | August 31, 2000 | 12, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA022272 OXYCONTIN | Knoa Pharma | April 5, 2010 | 35, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA200535 OXYCODONE HYDROCHLORIDE | Genus Lifesciences | October 20, 2010 | 17, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA202080 OXAYDO | Zyla | June 17, 2011 | 15, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA209777 ROXYBOND | Protega Pharms | April 20, 2017 | 11, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
Generic approvals (24)
- ANDA076758Specgx LLC · June 30, 2004
- ANDA077712Strides Pharma Intl · January 31, 2007
- ANDA091393Avanthi Inc · August 31, 2009
- ANDA091490Rhodes Pharms · March 9, 2011
- ANDA202116Alvogen · December 30, 2011
- ANDA202160Aurolife Pharma LLC · November 19, 2012
- ANDA204037Hikma · July 15, 2013
- ANDA203638Amneal Pharms · June 3, 2014
- ANDA204603Novel Labs Inc · April 29, 2015
- ANDA204979Ani Pharms · June 1, 2015
- ANDA202773Avanthi Inc · August 17, 2015
- ANDA204752Novel Labs Inc · August 24, 2015
- ANDA202662Epic Pharma LLC · September 22, 2015
- ANDA205177Ani Pharms · March 31, 2016
- ANDA207511Adaptis · November 23, 2016
- ANDA204021Novel Labs Inc · June 12, 2017
- ANDA208593Abhai LLC · July 21, 2017
- ANDA207418Ascent Pharms Inc · August 7, 2017
- ANDA209897Adaptis · September 6, 2017
- ANDA209021Ascent Pharms Inc · November 9, 2017
- ANDA210758Specgx LLC · April 30, 2018
- ANDA206914Pharm Assoc · February 1, 2019
- ANDA212429Aurolife Pharma LLC · January 27, 2020
- ANDA213761Quagen · June 2, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 14, 2026 · Class II · Ongoing · D-0338-2026
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health P — Amerisource Health Services LLC
-
October 20, 2023 · Class III · Ongoing · D-0094-2024
Sub-potent Drug: Lower potency than labeled.
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11 — Zyla Life Sciences US Inc.
-
February 22, 2022 · Class II · Terminated · D-0652-2022
Impurity failure at 0-time of the repackaged lot.
Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Cas — American Health Packaging
-
December 29, 2021 · Class III · Terminated · D-0358-2022
Out-of-specification impurity test result observed at 18-month long term stability time point.
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432- — Lupin Pharmaceuticals Inc.
-
August 19, 2021 · Class II · Terminated · D-0794-2021
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01 — Rhodes Pharmaceuticals, L.P.
-
December 23, 2020 · Class III · Terminated · D-0231-2021
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups) — Genus Lifesciences Inc.
-
January 22, 2018 · Class III · Terminated · D-0248-2018
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01 — Ascent Pharmaceuticals, Inc.
-
May 19, 2016 · Class III · Terminated · D-1441-2016
Failed Impurities/Degradation Specification; 9 month stability
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41 — West-Ward Columbus Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1049214, 1049225, 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1049604 … (+10) |
|---|---|
| SPL set ID of the quoted label | 5a8157d3-ba20-4abf-b0d4-6ad141b31d63 |
| FDA labels (SPL) | 86 |
| FDA applications | NDA021011, NDA022272, NDA200535, NDA202080, NDA209777, 24 ANDA |
| Active ingredients (FDA) | OXYCODONE HYDROCHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Roxicodone, SpecGx LLC, effective April 24, 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 →