SPL Set ID: d5be5f12-6392-4d7d-ab23-ebc205ac1a85

1 drug(s) with this SPL Set ID

Open DailyMed details

clarithromycin CLARITHROMYCIN
#31 500 mg Extended-release
ACTAVIS PHARMA, INC. FDA Rx Only

Clarithromycin, USP is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6-0­ methylerythromycin. The molecular formula is C 38 H 69 NO 13 , and the molecular weight is 747.95. The structural formula is: Figure 1: Structure of Clarithromycin Clarithromycin, USP is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each yellow oval film-coated unscored clarithromycin extended-release tablet, for oral administration, contains 500 mg of clarithromycin and the following inactive ingredients: compressible sugar, D&C yellow #10 Aluminum Lake, glycerol monostearate, polyethylene glycol 3000, polyvinyl alcohol, sodium phosphate monobasic (anhydrous), talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. 2

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