12 HR Bupropion Hydrochloride 150 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE 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 ( 14 )]. 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 ( 14 )] . • Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )
Eon Labs, Inc.
ROUND PURPLE E over 415
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE extended-release tablets, USP (SR), for oral administration, are available as 100 mg aquamarine, round, biconvex, film-coated tablets, debossed “ E ” over “410” on one side and plain on the other side and supplied as: NDC 0185-0410-60 bottles of 60 NDC 0185-0410-01 bottles of 100 NDC 0185-0410-52 bottles of 250 NDC 0185-0410-05 bottles of 500 150 mg Plum, round, biconvex, film-coated tablets, debossed “ E ” over “415” on one side and plain on the other side and supplied as: NDC 0185-0415-60 bottles of 60 NDC 0185-0415-01 bottles of 100 NDC 0185-0415-52 bottles of 250 NDC 0185-0415-05 bottles of 500 200 mg Light pink, round, biconvex, film-coated tablets, debossed “ E ” on one side and debossed “1111” on the other side and supplied as: NDC 0185-1111-60 bottles of 60 NDC 0185-1111-01 bottles of 100 NDC 0185-1111-52 bottles of 250 NDC 0185-1111-05 bottles of 500 NDC 0185-1111-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. Keep tightly closed. KEEP OUT OF THE REACH OF CHILDREN.
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