SPL Set ID: 1d4c9535-f185-4ea3-9140-60c4bb77f736
1 drug(s) with this SPL Set ID
Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4 β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a white to off-white to slightly yellow powder with the following chemical name: 7,8,9,10-Tetrahydro-6,10-methano-6 H -pyrazino[2,3- h ][3]benzazepine, (2 R ,3 R )-2,3-dihydroxybutanedioate (1:1). It is soluble in water, sparingly soluble in dimethylsulfoxide and slightly soluble in methanol and N,N -dimethylformamide. Varenicline tartrate has a molecular weight of 361.35, and a molecular formula of C 13 H 13 N 3 . C 4 H 6 O 6 . The chemical structure is: Varenicline tablets are supplied for oral administration in two strengths: a 0.5 capsule shaped, biconvex, white to off-white, film-coated tablet debossed with "ZV1" on one side and plain on the other side and a 1 mg capsule shaped, biconvex, light blue to blue, film-coated tablet debossed with "ZV2" on one side and plain on the other side. Each film-coated tablet contains 0.855 mg or 1.71 mg of varenicline tartrate equivalent to 0.5 mg or 1 mg of varenicline free base, respectively. Each tablet contains following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Additionally, each 1 mg tablet contains FD&C blue #1 aluminum lake. Image