Buprenorphine HCl and Naloxone HCl Buprenorphine 8 MG Naloxone 2 MG Sublingual Tablet
1 INDICATIONS AND USAGE Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )
Amneal Pharmaceuticals, LLC
ROUND ORANGE AN 415
AN 415 ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPRENORPHINE AND NALOXONE Sublingual Tablets USP, 2 mg/0.5 mg are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows: Bottles of 30 NDC 65162-416-03 Bottles of 90 NDC 65162-416-09
BUPRENORPHINE AND NALOXONE Sublingual Tablets USP, 8 mg/2 mg are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows: Bottles of 30 NDC 65162-415-03 Bottles of 90 NDC 65162-415-09 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store
BUPRENORPHINE AND NALOXONE Sublingual Tablets, USP securely and dispose of properly [see Patient Counseling Information (17) ] .
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