Source: FDA, National Drug Code (US) Revision Year: 2020
NORVASC is the besylate salt of amlodipine, a long-acting calcium channel blocker.
Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (Âą)- 2-[(2-aminoethoxy)methyl]- 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5âĒC6H6O 3S, and its structural formula is:
Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. NORVASC (amlodipine besylate) Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
| Dosage Forms and Strengths |
|---|
|
Tablets: 2.5 mg white, diamond, flat-faced, beveled edged, with “NORVASC” on one side and “2.5” on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, engraved with both “NORVASC” and “5” on one side and plain on the other Tablets: 10 mg white, round, flat-faced, beveled edged, engraved with both “NORVASC” and “10” on one side and plain on the other. |
| How Supplied |
|---|
|
5 mg Tablets: NORVASC – 5 mg Tablets (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both “NORVASC” and “5” on one side and plain on the other side and supplied as follows: NDC 55289-103-30 Bottle of 30 |
| Drug | Countries | |
|---|---|---|
| NORVASC | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Finland, Hong Kong, Croatia, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United States, South Africa |
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