SPL Set ID: fcd9aba6-87ea-4298-86f7-96bdcc0c1c2f

Azithromycin Tablets, USP contain the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2 R ,3 S ,4 R ,5 R ,8 R ,10 R ,11 R ,12 S ,13 S ,14 R )-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, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula: C 38 H 72 N 2 O 12 M.W. 749 Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 •H 2 O and a molecular weight of 767. Azithromycin Tablets, USP are supplied for oral administration as tablets containing azithromycin monohydrate equivalent to 250 mg azithromycin, USP and the following inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide. The 500 mg tablets also contain FD&C Blue #2. structural formula