Naltrexone tablets, injections, brands, and generics

Why the manufacturer is only one part of the answer

Approved generic tablets contain the same active drug and must meet the relevant regulator’s standards. That does not make every product literally identical. The labeler, manufacturing site, inactive ingredients, tablet appearance, pack, and current supply can differ.

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.

Use this page to identify the product layer, then check the live regulator record and a licensed pharmacy in the country where it will be supplied. Each entry is a product record, listed for identification only.

Selected oral naltrexone 50 mg records

These records establish particular approvals or labels; they are not a complete worldwide market inventory.

1. 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 The label is a historical reference and should not be treated as proof of current marketing or pharmacy stock.
2. 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.
3. 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.
4. 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.

1. 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.
2. 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 exact product. Confirm the active ingredient, strength, dosage form, brand name, and manufacturer shown on the original packaging and prescription.
• 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. ReVia prescribing information records the original oral approval year.
• Barr generic approval: 1998. FDA ANDA 074918 for 50 mg naltrexone hydrochloride tablets.
• Accord / Intas ANDA: 091205. Application number identified on the cited current DailyMed tablet label.
• Teva injectable approval: 2023. 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.

Take the exact product question to the country guide

Country pages separate oral naltrexone, Vivitrol, and combination medicines so a registration in one category is not mistaken for supply in another.

Compare country accessRead naltrexone basics

Sources

Checked July 26, 2026.

1. DailyMed: Accord naltrexone hydrochloride tablets 50 mg. Identifies the labeler, manufacturer, strength, and application record.
2. FDA approval letter: Teva extended-release injectable naltrexone, ANDA 213195
3. Current Vivitrol prescribing information (DailyMed). Reference-product formulation, indications, administration, and warnings.
4. FDA ReVia prescribing information. Historical oral reference-product label.