Check the exact product
Confirm the active ingredient, strength, dosage form, brand name, and manufacturer shown on the original packaging and prescription.
Evidence reviewed
Pharmaceutical manufacturers
Who Makes Naltrexone
A record-based guide to selected oral and injectable naltrexone products. Approval, labelling, manufacturing, and current marketing are separate facts, so each exact product should be verified in the relevant regulator's live database.
About this page
Naltrexone is manufactured by dozens of pharmaceutical companies worldwide. The active ingredient — naltrexone hydrochloride — is chemically identical regardless of who makes it. Brand names, tablet appearance, and price vary, but the therapeutic effect does not.
This page presents selected product records organised by formulation. Where a primary record identifies them, it includes an FDA application number, labeler, or manufacturer. A regulator's approval record does not by itself prove that a product is currently marketed, stocked, or available in every country.
Note: This is not an endorsement of any manufacturer or product. All naltrexone products discussed are prescription-only medications requiring medical supervision.
Selected oral naltrexone 50 mg records
These records establish particular approvals or labels; they are not a complete worldwide market inventory.
ReVia — historical US reference product
FDA prescribing information identifies ReVia as a 50 mg oral naltrexone hydrochloride tablet. The label is a historical reference and should not be treated as proof of current marketing or pharmacy stock.
Barr Laboratories — US generic approval
FDA ANDA 074918 records approval of Barr's naltrexone hydrochloride 50 mg tablets in May 1998. The approval package establishes the product record, not its current commercial availability.
Accord Healthcare / Intas — current US label record
The cited DailyMed label identifies Accord Healthcare as labeler, Intas Pharmaceuticals as manufacturer, and ANDA 091205 for naltrexone hydrochloride 50 mg tablets. DailyMed label presence should still be checked against current marketing and local stock.
Products outside the United States
Brand names and suppliers vary by country and over time. Use the relevant national regulator or formulary to confirm the exact active ingredient, strength, marketing status, manufacturer or labeler, and current pharmacy supply.
Selected injectable naltrexone records
Extended-release injectable products have distinct formulations, administration requirements, and product records from oral tablets.
Alkermes — Vivitrol reference product
Current FDA prescribing information identifies Vivitrol as naltrexone for extended-release injectable suspension, 380 mg per vial, administered by a healthcare professional. Check the live label and local supply rather than inferring availability from approval alone.
Teva — FDA generic approval in 2023
FDA's approval letter records ANDA 213195 for naltrexone extended-release injectable suspension, 380 mg per vial, approved 6 July 2023. The letter establishes approval and therapeutic equivalence; it does not establish current marketing, distribution, or pharmacy stock.
How to verify an Indian product
Retail listings and prices change quickly and were not accepted here as primary evidence of approval or supply.
Check the regulator or state authority
Use the applicable Indian drug-control record or ask a licensed pharmacist to confirm the manufacturer and product authorisation. A company name alone is not enough.
Check current price and stock locally
Ask a licensed pharmacy for the current pack size, maximum retail price, expiry, and stock. Do not rely on an undated online marketplace price.
Check imports in the destination country
A product sold in India is not automatically authorised elsewhere. Verify the destination country's regulator, import rules, prescription requirements, and pharmacy supply.
Selected US product milestones
Dated primary records are more durable than an undated count of manufacturers or patents.
- Oral naltrexone milestone
- 1984
- Barr generic approval
- 1998
- Accord / Intas ANDA
- 091205
- Teva injectable approval
- 2023
ReVia prescribing information records the original oral approval year
FDA ANDA 074918 for 50 mg naltrexone hydrochloride tablets
Application number identified on the cited current DailyMed tablet label
FDA ANDA 213195 for 380 mg extended-release injectable suspension
Frequently asked questions about naltrexone manufacturers
Does it matter which manufacturer produces my naltrexone?
An approved generic must meet the relevant regulator's quality and bioequivalence requirements, but products can differ in inactive ingredients, appearance, packaging, and supply. Confirm the exact product with a licensed pharmacist, especially if you have allergies or intolerances, and do not substitute oral and extended-release injectable formulations.
How should I assess an Indian generic product?
Assess the exact product record, not the manufacturer's nationality or reputation. Confirm the active ingredient, strength, authorisation, manufacturer, original packaging, expiry, licensed supply chain, and destination-country import rules with a regulator or licensed pharmacist.
Are there naltrexone implants?
Implant products have been used in some settings, but approval and evidence vary by jurisdiction and product. Do not infer that an implant is authorised from the approval of oral tablets or extended-release injection; check the exact product with the national regulator and a qualified clinician.
Who manufactures naltrexone in Australia?
Use the current Australian Register of Therapeutic Goods to identify authorised products and sponsors, then check the PBS separately for subsidy status. Product registration does not guarantee PBS listing or local pharmacy stock.
What is the status of the Teva generic injectable approved in 2023?
FDA's approval letter confirms ANDA 213195 and its approval date. That record alone does not prove current marketing or availability. Check the current FDA product record and ask the dispensing service about stock before making treatment plans.
How can I verify that my naltrexone is from a legitimate manufacturer?
Use the national regulator's product database, inspect the original labelled packaging, and ask a licensed pharmacist to confirm the manufacturer or labeler and supply chain. Approval, current marketing, and local stock are different checks.
Check access where you live
Product evidence and access differ by country. Use the country comparison to see what has been verified, what remains uncertain, and which local record to check next.
Primary product records
- DailyMed: Accord naltrexone hydrochloride tablets 50 mg
Identifies Accord as labeler, Intas as manufacturer, and ANDA 091205.
- FDA Vivitrol prescribing information
Current reference-product formulation and administration record.
- FDA ReVia prescribing information
Historical reference-product formulation and clinical label.