SPL Set ID: 7e467c02-49a0-4b62-b537-430fdfa4f10e

1 drug(s) with this SPL Set ID

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Extended Phenytoin Sodium PHENYTOIN SODIUM
AMNEAL PHARMACEUTICALS LLC FDA Rx Only

Phenytoin sodium, USP is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula: Each extended phenytoin sodium capsule, USP for oral administration contains 100 mg phenytoin sodium, USP. Each capsule also contains the following inactive ingredients: D&C Red #28, D&C Red #33, FD&C Blue #1, gelatin, hydroxypropyl cellulose, mannitol, magnesium stearate, talc and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules , USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Meets USP Dissolution Test 5. Struct Form.

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