Prescription medicine
Oxycodone Brand names: Oxycontin, Xtampza, Roxybond, Oxaydo; first approved as Roxicodone
Oxycodone (Oxycontin) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 32 generic labelers, and pharmacies paid $0.0884 per oxycodone HCl (ir) 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the oxycodone FDA label on DailyMed (effective May 6, 2026, Rhodes Pharmaceuticals LLC); the NDA 20932 record on Drugs@FDA; every oxycodone label on DailyMed.
Highlights of the record
FDA label of May 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE TABLETS.
See full prescribing information for complete boxed warning. Oxycodone hydrochloride tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of oxycodone hydrochloride tablets are essential. ( 5.2 ) Accidental ingestion of oxycodone hydrochloride tablets, especially by children, can result in a fatal overdose of oxycodone. ( 5.2 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. […]
Used for
From the label: indications and usageOxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Forms and strengths
- 5 mg
- 7.5 mg
- 9 mg
- 10 mg
- 13.5 mg
- 15 mg
- 18 mg
- 20 mg
- 27 mg
- 30 mg
- 36 mg
- 40 mg
Tablet; solution; film-coated extended-release tablet; extended-release capsule; coated tablet.
On the market
- Earliest approval on file
- October 26, 1998 Roxicodone, Roxane; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 45 first February 6, 2004; 25 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 38 of which 32 under generic applications, 7 under brand applications, repackagers included
- Last listed patent
- March 29, 2030 Oxycontin tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0884 per tablet Oxycodone HCl (ir) 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 11 since 2016 0 Class I among all firms' recalls; latest January 14, 2026
- FAERS reports
- 311,625 through July 30, 2026
What is oxycodone used for?
From the label: indications and usageOxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. […]
Conditions named in the indications of oxycodone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Oxycodone Hydrochloride), Rhodes Pharmaceuticals LLC, effective May 6, 2026 (SPL set a5162476-1217-41c0-bc7e-0a0f123f069f), via openFDA; the full label on DailyMed
Is there a generic for oxycodone (Oxycontin)?
The FDA approved the first generic oxycodone on February 6, 2004. 45 generic applications are approved; 25 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists oxycodone from 32 labelers under a generic (ANDA) application and from 7 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 15 patents for Oxycontin tablets, the last expiring on March 29, 2030; a patent listed only for Xtampza ER capsules runs to September 2, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1998 earliest approval on file
- 2004 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for oxycodone (Oxycontin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0884 per Oxycodone HCl (ir) 5 mg tablet, down 6% from $0.0944 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Oxycodone HCl (ir) 5 mg tablet (generic)
- Oxycontin ER 10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Oxycodone HCl (ir) 10 mg tablet | Generic | $0.163 per tablet | $4.88 | +0.1% |
| Oxycodone HCl (ir) 15 mg tablet | Generic | $0.197 per tablet | $5.90 | -10% |
| Oxycodone HCl (ir) 20 mg tablet | Generic | $0.246 per tablet | $7.39 | -0.3% |
| Oxycodone HCl (ir) 30 mg tablet | Generic | $0.357 per tablet | $10.71 | +2% |
| Oxycodone HCl (ir) 5 mg capsule | Generic | $0.375 per capsule | $11.24 | +1% |
| Oxycodone HCl (ir) 5 mg tablet | Generic | $0.0884 per tablet | $2.65 | -6% |
| Oxycodone HCl 100 mg/5 mL conc | Generic | $2.19 per mL | n/a | -11% |
| Oxycodone HCl 5 mg/5 mL solution | Generic | $0.0735 per mL | n/a | -8% |
| Oxycontin ER 10 mg tablet | Brand | $5.87 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $176.24 | +8% |
| Oxycontin ER 15 mg tablet | Brand | $8.66 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $259.81 | +8% |
| Oxycontin ER 20 mg tablet | Brand | $10.95 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $328.64 | +8% |
| Oxycontin ER 30 mg tablet | Brand | $15.22 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $456.67 | +8% |
| Oxycontin ER 40 mg tablet | Brand | $18.77 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $563.23 | +8% |
| Oxycontin ER 60 mg tablet | Brand | $26.54 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $796.11 | +8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has oxycodone been recalled?
The FDA's Enforcement Report lists 11 recalls naming oxycodone since 2016: 0 Class I (the most serious), 5 Class II, 6 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 14, 2026 | Class II | Amerisource Health Services LLC | Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. |
| October 20, 2023 | Class III | Zyla Life Sciences US Inc. | Sub-potent Drug: Lower potency than labeled. |
| February 22, 2022 | Class II | American Health Packaging | Impurity failure at 0-time of the repackaged lot. |
| December 29, 2021 | Class III | Lupin Pharmaceuticals Inc. | Out-of-specification impurity test result observed at 18-month long term stability time point. |
| December 3, 2021 | Class III | Akorn, Inc. | Labeling: Missing Label |
| August 19, 2021 | Class II | Rhodes Pharmaceuticals, L.P. | Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle |
| December 23, 2020 | Class III | Genus Lifesciences Inc. | Presence of Foreign Substance: Particulate matter was found in multiple lots of product. |
| January 22, 2018 | Class III | Ascent Pharmaceuticals, Inc. | Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the oxycodone label say about other medicines?
The oxycodone label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 18 other medicines name oxycodone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Buprenorphine | drug interactions | Clinical Impact: May reduce the analgesic effect of oxycodone hydrochloride tablets and/or may precipitate withdrawal symptoms. Intervention: Avoid concomitant use Butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of oxycodone hydrochloride tablets and/or may precipitate withdrawal symptoms. Intervention: Avoid concomitant use Butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Carbamazepine | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of oxycodone hydrochloride tablets and CYP3A4 inducers can decrease the plasma concentration of oxycodone, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical … intervals for signs of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin |
| Cyclobenzaprine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Erythromycin | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
| Gabapentin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Ketoconazole | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
| Linezolid | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metaxalone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Methylene blue | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Mirtazapine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those … |
| Morphine | drug interactions | Clinical Impact: The concomitant risk of anticholinergic drugs may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. … ( 7 ) Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of morphine. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI. |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of oxycodone hydrochloride tablets and/or may precipitate withdrawal symptoms. Intervention: Avoid concomitant use Butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Nalmefene | warnings and precautions | Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient's clinical status [see Overdosage (10) ]. |
Every other medicine the oxycodone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Naloxone | warnings and precautions | Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient's clinical … |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … pressure and signs and symptoms of CNS and respiratory depression. Examples: Phenelzine, tranylcypromine, linezolid |
| Phenytoin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of oxycodone hydrochloride tablets and CYP3A4 inducers can decrease the plasma concentration of oxycodone, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical … of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin |
| Pregabalin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Rifampin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of oxycodone hydrochloride tablets and CYP3A4 inducers can decrease the plasma concentration of oxycodone, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical … frequent intervals for signs of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin |
| Ritonavir | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
| Tramadol | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … signs and symptoms of CNS and respiratory depression. Examples: Phenelzine, tranylcypromine, linezolid |
| Trazodone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
Other labels that name oxycodone
Source: FDA drug label (Oxycodone Hydrochloride), Rhodes Pharmaceuticals LLC, effective May 6, 2026 (SPL set a5162476-1217-41c0-bc7e-0a0f123f069f), via openFDA; the full label on DailyMed
What do FAERS reports show for oxycodone?
The FDA Adverse Event Reporting System holds 311,625 reports that list oxycodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 74,855 are coded as a death and 71,489 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2021 (61,206, against a median of 14,507 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as oxycodone?
34 other medicines are given the same way (oral) and in the same FDA class as oxycodone or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Acetaminophen and codeine | Pain | 25 labelers | $0.256 per tablet 3 tablet | No current entry |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
| Oxymorphone | Pain | 9 labelers | n/a | No current entry |
| Tapentadol | Pain | 4 labelers | $14.48 per tablet 100 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does oxycodone compare with medicines for the same use?
16 side-by-side pages set oxycodone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to oxycodone
- 34 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Oxycodone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other