Source: FDA, National Drug Code (US) Revision Year: 2020
VUMERITY contains diroximel fumarate. The chemical name of diroximel fumarate is 2-Butenedioic acid (2E), 1[2-(2,5-dioxo-1-pyrrolidinyl)ethyl] 4-methyl ester, which has a molecular formula of C11H13NO6 and molecular weight of 255.22.
Diroximel fumarate has the following structure:
Diroximel fumarate is a white to off-white powder that is slightly soluble in water.
VUMERITY is provided as delayed-release capsules for oral administration. Each capsule contains 231 mg of diroximel fumarate and the following inactive ingredients: crospovidone, colloidal silicon dioxide, magnesium stearate (non-bovine), methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, talc, and triethyl citrate.
The capsule shell contains carrageenan, hypromellose, potassium chloride, and titanium dioxide. It is printed with black ink that contains iron oxide, potassium hydroxide, propylene glycol, and shellac.
| Dosage Forms and Strengths |
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VUMERITY is available as hard, delayed-release capsules containing 231 mg of diroximel fumarate. The capsules have a white cap and a white body, printed with “DRF 231 mg” in black ink on the body. |
| How Supplied |
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VUMERITY is available as delayed-release capsules for oral administration, containing 231 mg of diroximel fumarate. The 231 mg capsules have a white cap and a white body, printed with “DRF 231 mg” in black ink on the body. VUMERITY is available as follows: 30-day Starter dose bottle (bottle of 106 capsules), NDC 64406-020-01. 30-day Maintenance dose bottle (bottle of 120 capsules), NDC 64406-020-03. |
| Drug | Countries | |
|---|---|---|
| VUMERITY | Estonia, Finland, Ireland, Israel, Poland, Romania, United States |
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