Source: FDA, National Drug Code (US) Revision Year: 2020
Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula:
MYSOLINE (primidone) is a white, crystalline, highly stable substance, M.P. 279-284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog.
MYSOLINE 50 mg and 250 mg tablets contain the following inactive ingredients: lactose monohydrate, NF; magnesium stearate, NF; methylcellulose, USP; microcrystalline cellulose, NF; purified water, USP; sodium lauryl sulfate, NF; sodium starch glycolate, NF; and talc, USP.
MYSOLINE 250 mg tablets also contain ferric oxide yellow, NF.
| How Supplied |
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MYSOLINE Tablets: Modified square, flat faced, beveled edge, compressed light yellow color tablet. One face is debossed (impressed) with “MYSOLINE” and “250” that are divided by a debossed bisect line. The opposite side is embossed with the letter “M”, in bottles of 100 (NDC 66490-691-10). Modified square, flat faced, beveled edge, compressed white color tablet. One face is debossed (impressed) with “MYSOLINE” and “50” that are divided by a debossed bisect line. The opposite side is embossed with the letter “M”, in bottles of 100 (NDC 66490-690-10). Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc., Steinbach, MB R5G 1Z7, Canada |
| Drug | Countries | |
|---|---|---|
| MYSOLINE | Austria, Australia, Spain, France, Ireland, Malta, Mexico, Netherlands, Turkey, United States, South Africa |
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