bupropion hydrochloride
bupropion hydrochloride is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including Bupropion Hydrochloride (XL), Bupropion Hydrochloride SR, Bupropion Hydrochloride XL. Available dosage forms: tablet, film coated, extended release, tablet, extended release, powder.
Drug Details
- Generic Name
- bupropion hydrochloride
- Brand Names
- Bupropion Hydrochloride (XL), Bupropion Hydrochloride SR, Bupropion Hydrochloride XL, bupropion, bupropion hydrochloride SR, bupropion hydrochloride, WELLBUTRIN XL, BuPROPion Hydrochloride, buPropion Hydrochloride XL
- Application Number
- ANDA207479
- Sponsor
- REMEDYREPACK INC.
- NDC Codes
- 50
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, POWDER
- Routes
- ORAL
- Active Ingredients
- BUPROPION HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) ( 1.1 ) prevention of seasonal affective disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1) ]. 1.2 Seasonal Affective Disorder (SAD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies (14.2) ].