SPL Set ID: bf412e94-ca36-4da9-83d7-fb0f1323cf21
1 drug(s) with this SPL Set ID
Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below: 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide) 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide) 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide) 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide) Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2. Chemical Structure