Active substance
Naltrexone
- US FDA 10
- Health Canada 3
- US price lines 2
- NHS prices 1
- WHO EML 1
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| NALTREXONE HYDROCHLORIDE | 50MG | tablet · oral | BARR | Prescription | 8 May 1998 |
| NALTREXONE HYDROCHLORIDE | 50MG | tablet · oral | ELITE LABS | Prescription | 26 May 1999 |
| NALTREXONE HYDROCHLORIDE | 50MG | tablet · oral | NOVITIUM PHARMA | Prescription | 8 Mar 2000 |
| NALTREXONE HYDROCHLORIDE | 25MG; 50MG; 100MG | tablet · oral | SPECGX LLC | Prescription | 22 Mar 2002 |
| VIVITROL | 380MG/VIAL | for suspension, extended release · intramuscular | ALKERMES | Prescription | 13 Apr 2006 |
| NALTREXONE HYDROCHLORIDE | 50MG | tablet · oral | ACCORD HLTHCARE | Prescription | 17 Aug 2011 |
| NALTREXONE HYDROCHLORIDE | 50MG | tablet · oral | SUN PHARM | Prescription | 24 Feb 2012 |
| NALTREXONE HYDROCHLORIDE | 50MG | tablet · oral | CHARTWELL | Prescription | 21 Jul 2017 |
| REVIA | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | TEVA WOMENS | Discontinued | 20 Nov 1984 |
| NALTREXONE | 380MG/VIAL | for suspension, extended release · intramuscular | TEVA PHARMS USA INC | Discontinued | 6 Jul 2023 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-NALTREXONE | 02444275 | 50 MG | TABLET · ORAL | APOTEX INC |
| NALTREXONE HYDROCHLORIDE TABLETS USP | 02451883 | 50 MG | TABLET · ORAL | STERINOVA INC. |
| REVIA | 02213826 | 50 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | NALTREXONE 50 MG TABLET | $1.13746 | per EA | 23 Sep 2026 |
| US NADAC | VIVITROL 380 MG VIAL-DILUENT | $1716.11389 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Naltrexone 50mg tablets | £154.45 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 24.5.1. Medicines for alcohol use disorders · core
Disorders due to use of alcohol
Parenteral > General injections > IM: 380 mg in vial (extended-release) | Oral > Solid > tablet: 50 mg
Safety signals and safety-related labeling changes
- US FDA 22 Dec 2025 VIVITROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Nov 2025 CONTRAVE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 7 Oct 2019 EMBEDA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 16 Dec 2016 TROXYCA ER — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Naltrexone
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.