Bupropion HCl

FDA Drug Profile

Bupropion HCl is listed in the FDA National Drug Code directory with 3 NDC codes. Available dosage form: powder.

Drug Details

Generic Name
Bupropion HCl
Brand Names
N/A
Application Number
Sponsor
Darmerica, LLC
NDC Codes
3
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
BUPROPION HYDROCHLORIDE

Indications and Usage

Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].