SPL Set ID: df752bd4-e197-40a4-a01b-d48ba2c10516
1 drug(s) with this SPL Set ID
Glyburide and Metformin Hydrochloride Tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glyburide is 1-[[ p -[2-(5-chloro- o -anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C 23 H 28 ClN 3 O 5 S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N , N -dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white crystals with a molecular formula of C 4 H 12 ClN 5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown: Each glyburide and metformin hydrochloride tablet, USP intended for oral administration contains 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each tablet contains the following inactive ingredients: calcium carbonate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone. Additionally, 1.25 mg/250 mg tablets contain opadry II white 33F28398 which contains hypromellose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide. Additionally, 2.5 mg/500 mg tablets contain opadry II orange 31F530003 which contains FD&C blue #2 aluminum lake, FD&C yellow #5 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, polyethylene glycol and titanium dioxide. Additionally, 5 mg/500 mg tablets contain opadry II green 31F510000 which contains iron oxide black, iron oxide red, iron oxide yellow, hypromellose, lactose monohydrate, polyethylene glycol and titanium dioxide. figure figure