Is naltrexone FDA-approved?

Yes, as specific products: naltrexone hydrochloride tablets, Vivitrol and Contrave are FDA-approved for the uses in their labels. Drugs@FDA lists no product sold as low-dose naltrexone.

Checked 1 Nov 2026. The sources are below.

Naltrexone

Also: naltrexone hydrochloride

Status label in the Peptimes Library
Compoundable
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Treatment of alcohol dependence and blockade of the effects of exogenously administered opioids

    Source: DailyMed label, checked 1 Nov 2026

  • FDA status

    Treatment of alcohol dependence in patients able to abstain from alcohol in an outpatient setting before starting it, and prevention of relapse to opioid dependence following opioid detoxification, as part of a program that includes psychosocial support

    Source: DailyMed label, checked 1 Nov 2026

  • FDA status

    With a reduced-calorie diet and increased physical activity: "to reduce excess body weight and maintain weight reduction long term" in the adults with obesity or overweight that the label defines

    Source: DailyMed label, checked 1 Nov 2026

How to track it in Peptimes

Add naltrexone in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry is called “Low-Dose Naltrexone” and shows the status label “Compoundable”. That name isn’t an FDA-approved product: Drugs@FDA lists no naltrexone product sold as low-dose. The approved products above give the detail.

  • Logging: the amount you took and how you feel. It’s logged as oral, so there’s no injection site to record.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell naltrexone or any other compound.

More sources

  • FDA, Drugs@FDA: NDA 021897 (Vivitrol), NDA 200063 (Contrave) and NDA 018932 (Revia), checked 1 Nov 2026: product, route and marketing status. Revia is listed as discontinued, with a Federal Register determination that it wasn’t withdrawn for safety or effectiveness reasons; generic tablets are listed under “Naltrexone hydrochloride”.
  • FDA, Global Substance Registration System, Naltrexone, checked 1 Nov 2026: its formula, C20H23NO4. The hydrochloride salt has its own record.

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