Source: FDA, National Drug Code (US) Revision Year: 2019
MONUROL (fosfomycin tromethamine) Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2.
Its empirical formula is C3H7O4Pā¢C4H11NO3, and its chemical structure is as follows:
How Supplied |
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MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin. NDC:
Manufactured by: Zambon Switzerland Ltd., A Subsidiary of Zambon S.p.A, Via Industria 13, 6814 Cadempino, Switzerland Distributed by: Allergan USA, Inc., Madison, NJ 07940 |
Drug | Countries | |
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MONUROL | Canada, Ecuador, Spain, Hong Kong, Israel, Singapore, Turkey, United States |
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