Buprenorphine and Naloxone 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 and should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Prescription use of this product is limited under the Drug Addiction Treatment Act. ( 1 )
Teva Pharmaceuticals USA Inc
ROUND WHITE 5721 93
5721 93 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Buprenorphine and naloxone sublingual tablets are available as: 2 mg/0.5 mg: capsule-shaped, white to off-white tablets debossed with “93” on one side and “B9” on the other in bottles of 30 (NDC 0093-5720-56). 8 mg/2 mg: Convex, round, white to off-white tablets debossed with “93” on one side and “5721” on the other in bottles of 30 (NDC 0093-5721-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). CAUTION: DEA Order Form Required. Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. Destroy any unused medication appropriately [ see Disposal of Unused buprenorphine and naloxone sublingual tablets ( 17 ) ]. Rx only
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