FDA label
What is naltrexone used for?
The FDA-approved uses of naltrexone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Naltrexone Hydrochloride Tablets, USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.”
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Naltrexone Hydrochloride, tablet, film coated
Indications and Usage, quoted from the label by SpecGx LLC (ANDA076264). Cross-references to other label sections are left out.
Naltrexone Hydrochloride Tablets, USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.
Source: DailyMed label, set id 06ff2d5a-e62b-4fa4-bbdb-01938535bc65, version 15, effective September 4, 2026. NDC 0406-1170, one of 45 listings for this product.
Questions
What is naltrexone used for?
The FDA label says: “Naltrexone Hydrochloride Tablets, USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.”
What drug class is naltrexone?
FDA lists naltrexone in the Opioid Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.