FDA label
What is bupropion used for?
The FDA-approved uses of bupropion, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for bupropion hydrochloride (tablet, film coated, extended release) lists 2 uses: Major Depressive Disorder (MDD); Seasonal Affective Disorder (SAD).
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Bupropion Hydrochloride, tablet, extended release
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA216800). Cross-references to other label sections are left out.
Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion 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]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies].
Source: DailyMed label, set id f69b322b-93ab-407a-bf25-fe13c6896ca6, version 3, effective March 23, 2026. NDC 31722-066, one of 151 listings for this product.
Bupropion Hydrochloride, tablet, film coated, extended release
Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA216051). Cross-references to other label sections are left out.
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.
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.
Source: DailyMed label, set id cc344f7c-0eb3-4e63-a09e-b682acca2bb5, version 1, effective July 23, 2026. NDC 59651-511, one of 102 listings for this product.
Bupropion Hydrochloride, tablet, film coated
Indications and Usage, quoted from the label by NCS HealthCare of KY, LLC dba Vangard Labs (ANDA075491). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 4fbe64aa-f8f4-45fa-88ae-e844997703ae, version 2, effective July 2, 2026. NDC 0615-8581, one of 53 listings for this product.
Questions
What is bupropion used for?
The FDA label for bupropion hydrochloride (tablet, film coated, extended release) lists 2 uses: Major Depressive Disorder (MDD); Seasonal Affective Disorder (SAD).
What drug class is bupropion?
FDA lists bupropion in the Aminoketone established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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