Quick answers
- What is Naltrexone hydrochloride and bupropion hydrochloride used for?
- The FDA-approved label (Contrave Extended-Release, Nalpropion Pharmaceuticals LLC, November 10, 2025) says: “CONTRAVE is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Naltrexone hydrochloride and bupropion hydrochloride have a boxed warning?
- Yes. The FDA label for Contrave Extended-Release has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS WARNING: SUICIDAL THOUGHTS AND BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Naltrexone hydrochloride and bupropion hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Naltrexone hydrochloride and bupropion hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started October 5, 2018 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Naltrexone hydrochloride and bupropion hydrochloride?
- 1 company lists prescription products of Naltrexone hydrochloride and bupropion hydrochloride in the FDA NDC Directory, including Nalpropion Pharmaceuticals LLC.
What Naltrexone hydrochloride and bupropion hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CONTRAVE is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. …
— FDA label: Contrave Extended-Release, Nalpropion Pharmaceuticals LLC, effective November 10, 2025. Read the full label on DailyMed →
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.
This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, extended release |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Contrave Extended-Release |
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.
- Nalpropion Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA200063 CONTRAVE | Azurity | September 10, 2014 | 13, latest November 5, 2025 2025: Labeling · 2025: Labeling · 2024: Labeling |
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.
-
October 5, 2018 · Class III · Terminated · D-0219-2019
Container packaging defect.
Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99 — Orexigen Therapeutics, Inc.
-
August 9, 2018 · Class III · Terminated · D-1099-2018
Defective Container: Customer complaints of punctures in the bottle.
Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99. — Orexigen Therapeutics, Inc.
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) | 1551468, 1551474 |
|---|---|
| SPL set ID of the quoted label | 485ff360-32c8-11df-928b-0002a5d5c51b |
| FDA labels (SPL) | 1 |
| FDA applications | NDA200063 |
| Active ingredients (FDA) | BUPROPION / NALTREXONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Contrave Extended-Release, Nalpropion Pharmaceuticals LLC, effective November 10, 2025; 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 →