SPL Set ID: a5980bc8-8de8-c456-e053-2a95a90a792e

1 drug(s) with this SPL Set ID

Open DailyMed details

METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE
#4 500 mg Extended-release
GRANULES PHARMACEUTICALS INC. FDA Rx Only

Metformin hydrochloride extended-release tablet USP contains the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is 1,1-Dimethylbiguanide monohydrochloride. The structural formula is as shown: Metformin hydrochloride USP is a white crystalline powder with a molecular formula of C 4 H 11 N 5 .HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 10% aqueous solution of metformin hydrochloride is 7.45. Metformin hydrochloride extended-release tablets USP contain 500 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each 500 mg and 1000 mg tablet contains ammonio methacrylate copolymer type A, hypromellose, magnesium stearate, povidone, talc, triethyl citrate. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12. metformin-structure-jpg

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