SPL Set ID: 595ab888-6b55-4642-a32f-e8521821ed81

1 drug(s) with this SPL Set ID

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Atorvastatin Calcium ATORVASTATIN CALCIUM
#3 10 mg Tablet
SUN PHARMACEUTICAL INDUSTRIES INC. FDA Rx Only

Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium trihydrate, USP is [R-(R * ,R * )]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium trihydrate, USP is (C 33 H 34 FN 2 O 5 ) 2 Ca•3H 2 O and its molecular weight is 1209.41. Its structural formula is: Atorvastatin calcium trihydrate, USP is a white to off-white crystalline powder. Atorvastatin calcium trihydrate, USP is freely soluble in methanol, slightly soluble in alcohol, insoluble in water, acetonitrile and aqueous solution of pH 4 and below and very slightly soluble in pH 7.4 phosphate buffer. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin calcium trihydrate, USP equivalent to 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate; croscarmellose sodium; hydroxypropyl cellulose; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polysorbate 80; simethicone emulsion; talc, and titanium dioxide. Structure

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