Source: FDA, National Drug Code (US) Revision Year: 2019
Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate.
The structural formula is as follows:
(C9H13N)2·H2SO4 M.W = 368.49
Each tablet, for oral administration, contains dextroamphetamine sulfate, USP in either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg or 30 mg. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, microcrystalline cellulose and stearic acid.
The 5 mg tablets also contain D&C Red #27 and FD&C Yellow #6. The 7.5 mg tablets also contain FD&C Blue #1 and D&C Yellow #10. The 10 mg tablets also contain FD&C Red #40, FD&C Yellow #6 and FD&C Blue #2. The 15 mg tablets also contain FD&C Blue #1, FD&C Blue #2, and FD&C Red #40. The 20 mg tablets also contain FD&C Blue #1 and D&C Red #27. The 30 mg tablets also contain D&C Yellow #10.
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Zenzedi (dextroamphetamine sulfate tablets, USP) is supplied as follows: 2.5 mg: White, square tablet, debossed “2.5” on one side and “MIA” on the other side in bottles of 100 tablets, NDC 24338-850-10. 5 mg: Pink, oval tablet, debossed “5” on one side and “MIA” score on the other side in bottles of 100 tablets, NDC 24338-851-10. 7.5 mg: Light green, triangle tablet, debossed “7.5” on one side and “MIA” on the other side in bottles of 100 tablets, NDC 24338-852-10. 10 mg: Peach, round tablet, double scored on one side and debossed “10” over “MIA” on the other side in bottles of 100 tablets, NDC 24338-853-10. 15 mg: Light blue, pentagon tablet, debossed “15” on one side and “MIA” on the other side in bottles of 100 tablets, NDC 24338-854-10. 20 mg: Purple, capsule-shaped tablet, debossed “20” on one side and “MIA” on the other side in bottles of 100 tablets, NDC 24338-855-10. 30 mg: Light yellow, hexagon tablet, debossed “30” on one side and “MIA” on the other side in bottles of 100 tablets, NDC 24338-856-10. Dispense in well-closed containers as defined in the USP. Manufactured for: Arbor Pharmaceuticals, LLC, Atlanta, GA 30328 |
| Drug | Countries | |
|---|---|---|
| ZENZEDI | United States |
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