SPL Set ID: cc55110f-1ad6-4f97-840d-62b3a5ac415a

1 drug(s) with this SPL Set ID

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Fluvastatin Sodium FLUVASTATIN SODIUM
80 mg Extended-release
TEVA PHARMACEUTICALS USA, INC. FDA Rx Only

Fluvastatin sodium, USP inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium, USP is [ R * , S * -( E )]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1 H- indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The structural formula is: C 24 H 25 FNNaO 4 M.W. 433.46 Fluvastatin sodium, USP (hydrated form) is a white to pale yellow, brownish-pale yellow, or reddish-pale yellow hygroscopic powder soluble in water, ethanol and methanol. Fluvastatin Sodium Extended-Release Tablets contains 84.24 mg of fluvastatin sodium, USP (hydrated form), equivalent to 80 mg of fluvastatin, for oral use. Fluvastatin sodium extended-release tablets contain the following inactive ingredients: crospovidone, hydroxyethyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide. fluvastatin sodium structural formula

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