Source: FDA, National Drug Code (US) Revision Year: 2020
ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OâĒC4H4O4.
The molecular weight is 417.47 and the structural formula is:
Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate.
| Dosage Forms and Strengths |
|---|
|
ZELNORM Tablets: 6 mg tegaserod; supplied as whitish to slightly yellowish, round flat tablet with a beveled edge engraved with “ZEL” and “6”. |
| How Supplied |
|---|
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ZELNORM is supplied as 6 mg tegaserod whitish to slightly yellowish, round flat tablets with a beveled edge engraved with “ZEL” and “6”. Unit Dose (blister pack)
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| Drug | Countries | |
|---|---|---|
| ZELNORM | Estonia, United States |
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