SPL Set ID: 33140df5-420d-469f-b6c8-121e952a5cb6

Azithromycin for oral suspension, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38 H 72 N 2 O 12 and its molecular weight is 749. Azithromycin dihydrate, USP has the following structural formula: Azithromycin dihydrate, USP, is a white or almost white powder with a molecular formula of C 38 H 72 N 2 O 12 .2H 2 O and a molecular weight of 785.02. It is freely soluble in anhydrous ethanol and in methylene chloride and practically insoluble in water. Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; trisodium phosphate anhydrous, hydroxypropyl cellulose; xanthan gum; FD&C Red #40; cherry flavor, ripe banana flavor. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin. Azithromycin dihydrate