buprenorphine hydrochloride 11.4 mg naloxone hydrochloride 2.9 mg
1 INDICATIONS AND USAGE ZUBSOLV is indicated for treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support. ZUBSOLV contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )
orexo us, inc.
OVAL WHITE 11 4
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16 HOW SUPPLIED / STORAGE AND HANDLING ZUBSOLV sublingual tablets are menthol-flavored white tablets supplied in aluminum/aluminum child resistant unit dose blister packages. ZUBSOLV is available in six dosage strengths imprinted in their respective buprenorphine strength Buprenorphine 0.7 mg /naloxone 0.18 mg, oval shape, imprinted with “.7” Buprenorphine 1.4 mg /naloxone 0.36 mg, triangular shape, imprinted with “1.4” Buprenorphine 2.9 mg /naloxone 0.71mg, D shape, imprinted with “2.9” Buprenorphine 5.7 mg /naloxone 1.4 mg, round shape, imprinted with “5.7” Buprenorphine 8.6 mg /naloxone 2.1 mg, diamond shape, imprinted with “8.6” Buprenorphine 11.4 mg /naloxone 2.9 mg, capsule shape, imprinted with “11.4” NDC 54123-907-30 (buprenorphine 0.7 mg /naloxone 0.18 mg) sublingual tablet – 3x10 tablets per carton NDC 54123-914-30 (buprenorphine 1.4 mg /naloxone 0.36 mg) sublingual tablet – 3x10 tablets per carton NDC 54123-929-30 (buprenorphine 2.9 mg /naloxone 0.71 mg) sublingual tablet – 3x10 tablets per carton NDC 54123-957-30 (buprenorphine 5.7 mg /naloxone 1.4 mg) sublingual tablet – 3x10 tablets per carton NDC 54123-986-30 (buprenorphine 8.6 mg /naloxone 2.1 mg) sublingual tablet – 3x10 tablets per carton NDC 54123-114-30 (buprenorphine 11.4 mg /naloxone 2.9 mg) sublingual tablet – 3x10 tablets per carton Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] Store ZUBSOLV securely and dispose of properly [see Patient Counseling Information ( 17 )].
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