Acetaminophen and oxycodone Brand names: Endocet, Prolate, Percocet, Nalocet; first approved as Xartemis Xr

What is acetaminophen and oxycodone used for?

From the label: indications and usage

Oxycodone and acetaminophen tablets are 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 [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Conditions named in the indications of acetaminophen and oxycodone's FDA labels, with every medicine labeled for each:

• Pain

From other acetaminophen and oxycodone labels

Pain: INDICATIONS AND USAGE Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

FDA pharmacologic class: Opioid Agonist.

Is there a generic for acetaminophen and oxycodone (Percocet)?

The FDA approved the first generic acetaminophen and oxycodone on August 31, 1976. 64 generic applications are approved; 20 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 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists acetaminophen and oxycodone from 29 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 12 patents for Xartemis XR tablets, the last expiring on May 16, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What do pharmacies pay for acetaminophen and oxycodone (Percocet)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.183 per Oxycodone-acetaminophen 7.5-325 mg tablet, up 2% from $0.179 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.

Is acetaminophen and oxycodone in shortage?

No acetaminophen and oxycodone presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 5 records are all marked to be discontinued, the latest updated November 3, 2025. ASHP keeps a separate shortage list, which can differ.

Every acetaminophen and oxycodone presentation in the FDA shortage database

Has acetaminophen and oxycodone been recalled?

The FDA's Enforcement Report lists 8 recalls naming acetaminophen and oxycodone since 2013: 0 Class I (the most serious), 6 Class II, 2 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.

What does the acetaminophen and oxycodone label say about other medicines?

The acetaminophen and oxycodone label names 26 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Every other medicine the acetaminophen and oxycodone label names

Check acetaminophen and oxycodone against other medicines

What do FAERS reports show for acetaminophen and oxycodone?

The FDA Adverse Event Reporting System holds 23,353 reports that list acetaminophen and oxycodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,983 are coded as a death and 4,385 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 2023 (9,274, against a median of 1,209 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.

Reports received each year

• 1,045
• 793
• 1,209
• 1,231
• 1,497
• 1,781
• 950
• 9,274
• 1,618
• 941
• 424

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The most reported reactions

• Dependence (named in the label)8,736
• Overdose (a use or a product term, not a reaction)4,119
• Ill-Defined Disorder3,101
• Drug Ineffective (a use or a product term, not a reaction)1,924
• Pain (a use or a product term, not a reaction)1,819
• Death (an outcome recorded in the report)1,688
• Fatigue (named in the label)1,629
• Nausea (named in the label)1,446

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as acetaminophen and oxycodone?

27 other medicines are given the same way (oral) and in the same FDA class as acetaminophen and 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.

Every medicine labeled for the same conditions as acetaminophen and oxycodone

What next?

Alternatives to acetaminophen and oxycodone

27 medicines for the same use

Other opioids

the pharmacologic class, with prices and generics

Acetaminophen and oxycodone side effects

the label's list beside FAERS reports

Acetaminophen and oxycodone shortage record

every presentation, company and date

Check an interaction

what two or more labels say about each other