Prescription medicine
Naltrexone Brand names: Vivitrol; first approved as Revia
Naltrexone (Revia) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 21 generic labelers, and pharmacies paid $1.14 per naltrexone 50 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $1,716.11 per vial (Vivitrol 380 mg vial-diluent).
- Generic listed
Check it at the source: the naltrexone FDA label on DailyMed (effective September 4, 2026); the NDA 18932 record on Drugs@FDA; every naltrexone label on DailyMed.
Highlights of the record
FDA label of September 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageNaltrexone Hydrochloride Tablets, USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.
Forms and strengths
- 50 mg
Film-coated tablet; kit.
On the market
- Earliest approval on file
- November 20, 1984 Revia, Teva Womens; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first May 8, 1998; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 21 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 15, 2029 Vivitrol injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.14 per tablet Naltrexone 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2012 0 Class I among all firms' recalls; latest April 13, 2022; 7 more by firms not listed as its makers
- FAERS reports
- 32,067 through July 30, 2026
What is naltrexone used for?
From the label: indications and usageNaltrexone Hydrochloride Tablets, USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone Hydrochloride Tablets, USP have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
Conditions named in the indications of naltrexone's FDA labels, with every medicine labeled for each:
From other naltrexone labelsAlcohol use disorder: INDICATIONS AND USAGE Naltrexone Hydrochloride Tablets, USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.
Opioid use disorder: VIVITROL is indicated for the prevention of relapse to opioid dependence, following opioid detoxification ( 1.2 ).
FDA pharmacologic class: Opioid Antagonist.
Source: FDA drug label (NALTREXONE HYDROCHLORIDE), SpecGx LLC, effective September 4, 2026 (SPL set 06ff2d5a-e62b-4fa4-bbdb-01938535bc65), via openFDA; the full label on DailyMed
What does the patient leaflet for naltrexone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VIVITROL?VIVITROL can cause serious side effects, including: Risk of opioid overdose. You can accidentally overdose in two ways. VIVITROL blocks the effects of opioids, such as heroin or opioid pain medicines. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of VIVITROL. This can lead to serious injury, coma, or death. After you receive a dose of VIVITROL, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with VIVITROL can lead to overdose and death. […] Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with VIVITROL: stomach area pain lasting more than a few days dark urine yellowing of the whites of your eyes tiredness Your healthcare provider may need to stop treating you with VIVITROL if you get signs or symptoms of a serious liver problem. […]
From the patient leaflet: What should I avoid while receiving VIVITROL?Do not drive a car, operate machinery, or do other dangerous activities until you know how VIVITROL affects you. VIVITROL may make you feel dizzy and sleepy. See “ What are the possible side effects of VIVITROL? ”
Source: FDA drug label (VIVITROL), Alkermes, Inc., effective May 31, 2026 (SPL set cd11c435-b0f0-4bb9-ae78-60f101f3703f), via openFDA; the full label on DailyMed
Is there a generic for naltrexone (Revia)?
The FDA approved the first generic naltrexone on May 8, 1998. 8 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists naltrexone from 21 labelers under a generic (ANDA) application and from 2 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 no patent for Revia tablets; a patent listed only for Vivitrol injection runs to October 15, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1984 earliest approval on file
- 1998 first generic approved
- 2029 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 naltrexone (Revia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.14 per Naltrexone 50 mg tablet, down 11% from $1.28 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.
- Naltrexone 50 mg tablet (generic)
- Vivitrol 380 mg vial-diluent (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Naltrexone 50 mg tablet | Generic | $1.14 per tablet | $34.12 | -11% |
| Vivitrol 380 mg vial-diluent | Brand | $1,716.11 per vial many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has naltrexone been recalled?
The FDA's Enforcement Report lists 12 recalls naming naltrexone since 2012: 0 Class I (the most serious), 12 Class II, 0 Class III; 0 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of naltrexone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| April 6, 2020 | Class II | The Medicine Shoppe Pharmacy not a listed maker | Lack of Processing Control |
| December 18, 2019 | Class II | MPRX, Inc. dba Medical Park Pharmacy not a listed maker | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. |
| September 26, 2019 | Class II | Alkermes, Inc. | Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as … |
| August 8, 2019 | Class II | Alkermes Inc | Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as … |
| March 22, 2018 | Class II | Partell Specialty Pharmacy not a listed maker | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. |
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
| February 12, 2015 | Class II | Health Innovations Pharmacy, Inc not a listed maker | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the naltrexone label say about other medicines?
The naltrexone label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name naltrexone. 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 | contraindications | Patients currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine). |
| Carboxymethylcellulose | contraindications | Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent [see Warnings and Precautions ( 5.8 )]. |
| Disulfiram | drug interactions | The safety and efficacy of concomitant use of naltrexone hydrochloride and disulfiram is unknown, and the concomitant use of two potentially hepatotoxic medications is not ordinarily recommended unless the probable benefits outweigh the known risks. |
| Methadone | contraindications | Patients currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine). |
| Nalmefene | warnings | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose When initiating and renewing treatment with naltrexone hydrochloride, inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene) and discuss the importance of having access to an … |
| Naloxone | contraindications | Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids. |
| Thioridazine | drug interactions | Lethargy and somnolence have been reported following doses of naltrexone hydrochloride and thioridazine. |
| Tramadol | warnings | To prevent occurrence of precipitated withdrawal in patients dependent on opioids, or exacerbation of a pre-existing subclinical withdrawal syndrome, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting naltrexone hydrochloride … |
Other labels that name naltrexone
Source: FDA drug label (NALTREXONE HYDROCHLORIDE), SpecGx LLC, effective September 4, 2026 (SPL set 06ff2d5a-e62b-4fa4-bbdb-01938535bc65), via openFDA; the full label on DailyMed
What do FAERS reports show for naltrexone?
The FDA Adverse Event Reporting System holds 32,067 reports that list naltrexone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,395 are coded as a death and 4,356 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 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 naltrexone?
2 other medicines are given the same way (oral) and in the same FDA class as naltrexone or labeled mainly for the same use (alcohol use disorder), the same class first. Alcohol use disorder lists all 5 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Acamprosate | Alcohol use disorder | 10 labelers | $0.589 per tablet 333 mg tablet | No current entry |
| Disulfiram | Alcohol use disorder | 5 labelers | $1.82 per tablet 250 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does naltrexone compare with medicines for the same use?
2 side-by-side pages set naltrexone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other opioid antagonists
- the pharmacologic class, with prices and generics
- Naltrexone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other