Source: FDA, National Drug Code (US) Revision Year: 2020
Montelukast sodium, the active ingredient in SINGULAIR, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast sodium is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt.
The empirical formula is C35H35ClNNaO3S, and its molecular weight is 608.18.
The structural formula is:
Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.
Each 10-mg film-coated SINGULAIR tablet contains 10.4 mg montelukast sodium, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The film coating consists of: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, red ferric oxide, yellow ferric oxide, and carnauba wax.
Each 4-mg and 5-mg chewable SINGULAIR tablet contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, red ferric oxide, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate.
Each packet of SINGULAIR 4-mg oral granules contains 4.2 mg montelukast sodium, which is equivalent to 4 mg of montelukast. The oral granule formulation contains the following inactive ingredients: mannitol, hydroxypropyl cellulose, and magnesium stearate.
| Dosage Forms and Strengths |
|---|
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| How Supplied |
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No. 3841 – SINGULAIR Oral Granules, 4 mg, are white granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows: NDC 0006-3841-30 unit of use carton with 30 packets. No. 6628 – SINGULAIR Tablets, 4 mg, are pink, oval, bi-convex-shaped chewable tablets, with code MSD 711 on one side and SINGULAIR on the other. They are supplied as follows: NDC 0006-1711-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. No. 6543 – SINGULAIR Tablets, 5 mg, are pink, round, bi-convex-shaped chewable tablets, with code MSD 275 on one side and SINGULAIR on the other. They are supplied as follows: NDC 0006-9275-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. No. 6558 – SINGULAIR Tablets, 10 mg, are beige, rounded square-shaped, film-coated tablets, with code MSD 117 on one side and SINGULAIR on the other. They are supplied as follows: NDC 0006-9117-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-9117-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA |
| Drug | Countries | |
|---|---|---|
| SINGULAIR | Austria, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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