naltrexone hydrochloride and bupropion hydrochloride
naltrexone hydrochloride and bupropion hydrochloride is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Contrave Extended-Release. Available dosage form: tablet, extended release.
Drug Details
- Generic Name
- naltrexone hydrochloride and bupropion hydrochloride
- Brand Names
- Contrave Extended-Release
- Application Number
- NDA200063
- Sponsor
- Nalpropion Pharmaceuticals LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- NALTREXONE HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE 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. CONTRAVE is a combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, 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. ( 1 ) Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. ( 1 ) Coadministration with other naltrexone-containing products is not recommended. Coadministration with other bupropion-containing products is contraindicated. ( 1 , 4 ) Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. CONTRAVE contains naltrexone and bupropion. Coadministration with other naltrexone-containing products is not recommended. Coadministration with other bupropion-containing products is contraindicated.