SPL Set ID: eaf135b6-e378-4f62-a1e7-db45e23668c7

Dapagliflozin and Metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C -[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C 21 H 25 ClO 6 •C 3 H 8 O 2 •H 2 O and the formula weight is 502.98. The structural formula is: Dapagliflozin chemical structure Metformin HCl Metformin HCl ( N,N -dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is: Metformin hydrochloride chemical structure Dapagliflozin and Metformin HCl extended-release tablets Dapagliflozin and Metformin HCl extended-release tablets are available for oral administration as tablets containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (Dapagliflozin and Metformin HCl extended-release tablets 5 mg/1,000 mg), or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (Dapagliflozin and Metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of Dapagliflozin and Metformin HCl extended-release tablets contains the following inactive ingredients: anhydrous lactose, carboxymethylcellulose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film coatings contain the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.