"10135-603-01" National Drug Code (NDC)

Extended Phenytoin Sodium 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-603-01)
(Marlex Pharmaceuticals Inc)

NDC Code10135-603-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-603-01)
Product NDC10135-603
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameExtended Phenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20150801
Marketing Category NameANDA
Application NumberANDA040765
ManufacturerMarlex Pharmaceuticals Inc
Substance NamePHENYTOIN SODIUM
Strength100
Strength Unitmg/1
Pharmacy ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]

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