SPL Set ID: 654b7e08-33d8-47e7-b37f-3681e79c7b8b

The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3 S ,8 S ,9 S ,12 S )-3,12-Bis(1,1-dimethylethyl)-8­ hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13­ pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C 38 H 52 N 6 O 7 ●H 2 SO 4 , which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula: Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3 ○ C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol. structural formula