Quick answers
- What is Naltrexone hydrochloride used for?
- The FDA-approved label (Naltrexone Hydrochloride, Remedyrepack Inc., September 8, 2026) says: “Naltrexone 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Naltrexone hydrochloride have a boxed warning?
- No. None of the 43 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Naltrexone hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Naltrexone hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Naltrexone hydrochloride?
- 21 companies list prescription products of Naltrexone hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC and Precision Dose, Inc..
What Naltrexone hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Naltrexone 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.
— FDA label: Naltrexone Hydrochloride, Remedyrepack Inc., effective September 8, 2026. Read the full label on DailyMed →
The FDA has 43 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 43 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 45 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| naltrexone hydrochloride 50 mg tablet, film coated | Generic | $1.12 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack18 products
- Aphena Pharma Solutions - Tennessee, LLC4 products
- Precision Dose, Inc.2 products
- A-S Medication Solutions2 products
- Remedyrepack Inc.2 products
- Coupler LLC2 products
- Chartwell RX, LLC1 product
- NuCare Pharmaceuticals, Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Redpharm Drug1 product
- American Health Packaging1 product
- Proficient Rx LP1 product
- Major Pharmaceuticals1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Elite Laboratories, Inc.1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Accord Healthcare Inc.1 product
- AvKARE1 product
- TAGI Pharma, Inc.1 product
- SpecGx LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA075274Elite Labs · May 26, 1999
- ANDA076264Specgx LLC · March 22, 2002
- ANDA091205Accord Hlthcare · August 17, 2011
- ANDA090356Sun Pharm · February 24, 2012
- ANDA207905Chartwell · July 21, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1039-2022
cGMP deviations: Temperature abuse
Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1483744 |
|---|---|
| SPL set ID of the quoted label | db911559-26f5-43a0-b61f-3425176c936f |
| FDA labels (SPL) | 43 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | NALTREXONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Naltrexone Hydrochloride, Remedyrepack Inc., effective September 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →