Source: FDA, National Drug Code (US) Revision Year: 2020
MAYZENT tablets contains siponimod, an S1P receptor modulator, as 2:1 co-crystal of siponimod and fumaric acid and has the following chemical name:
1-[[4-[(1E)1[[[4-Cyclohexyl-3-(trifluoromethyl)phenyl]methoxy]imino]ethyl]-2-ethylphenyl]methyl]-3-azetidinecarboxylic acid (2E)-2-butenedioate (2:1). Its molecular formula is C4H4O4• 2C29H35F3N2O3, and its molecular weight is 1149.29 g/mol.
Its structure is shown below:
It is a white to almost white powder.
MAYZENT is provided as 0.25 mg and 2 mg film-coated tablets for oral use. Each tablet contains 0.25 mg or 2 mg siponimod, equivalent to 0.28 mg or 2.22 mg as 2:1 co-crystal of siponimod and fumaric acid, respectively.
MAYZENT tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, lactose monohydrate, microcrystalline cellulose, with a film coating containing iron oxides (black and red iron oxides for the 0.25 mg strength and red and yellow iron oxides for the 2 mg strength), lecithin (soy), polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.
| Dosage Forms and Strengths |
|---|
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0.25 mg tablet: Pale red, unscored, round biconvex film-coated tablet with beveled edges, debossed with 2 mg tablet: Pale yellow, unscored, round biconvex film-coated tablet with beveled edges, debossed with |
| How Supplied |
|---|
|
MAYZENT film-coated tablets are supplied as follows: 0.25 mg tablet: Pale red, unscored, round biconvex film-coated tablet with beveled edges, debossed with p=. Starter Pack* – blister card of twelve 0.25 mg tablets in a calendarized blister wallet – NDC 0078-0979-12 * This starter pack is only intended for patients who will receive the 2 mg maintenance dosage. Bottle of 28 tablets – NDC 0078-0979-50 2 mg tablet: Pale yellow, unscored, round biconvex film-coated tablet with beveled edges, debossed with p=. Bottle of 30 tablets – NDC 0078-0986-15 Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 |
| Drug | Countries | |
|---|---|---|
| MAYZENT | Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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on one side and ‘T’ on other side.