SPL Set ID: 4c7626c6-2b1b-4865-818c-0c79c18c049d

1 drug(s) with this SPL Set ID

Open DailyMed details

Dimethyl Fumarate, DIMETHYL FUMARATE DIMETHYL FUMARATE
120 mg Delayed-release
AMNEAL PHARMACEUTICALS NY LLC FDA Rx Only

Dimethyl fumarate delayed-released capsules, USP contain dimethyl fumarate, USP which is also known by its chemical name, dimethyl (E) butenedioate, (C 6 H 8 O 4 ). It has the following structure: Dimethyl fumarate, USP is a white to off-white powder. It is soluble in dichloromethane, N, N dimethyl formamide and sparingly soluble in methanol. Dimethyl fumarate delayed-released capsules, USP are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid copolymer Type A, methacrylic acid copolymer dispersion Type C, microcrystalline cellulose, silicified microcrystalline cellulose (microcrystaline cellulose & colloidal silicon dioxide), talc and triethyl citrate. The hard gelatin capsule shells contain: D&C yellow No. 10, FD&C blue No. 1, gelatin, sodium lauryl sulfate and titanium dioxide. Each capsule shell is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac glaze. 10

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