DEXEDRINE SPANSULE Extended-release capsule Ref.[10793] Active ingredients: Dexamfetamine

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

DEXEDRINE (dextroamphetamine sulfate) 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 DEXEDRINE as the neutral sulfate.

Structural formula:

SPANSULE capsules

Each SPANSULE sustained-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period.

Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. The 10-mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. The 15-mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.

How Supplied

DEXEDRINE SPANSULE capsules.

Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate.

The 5-mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body.

The 10-mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body.

The 15-mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body.

5 mg 90s: NDC 64896-673-10
10 mg 90s: NDC 64896-674-10
15 mg 90s: NDC 64896-675-10

Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391

Distributed by: Amneal Specialty, a division of Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Drugs

Drug Countries
DEXEDRINE Canada, United States

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