"65862-692-78" National Drug Code (NDC)

Extended Phenytoin Sodium 10 BLISTER PACK in 1 CARTON (65862-692-78) / 10 CAPSULE in 1 BLISTER PACK (65862-692-10)
(Aurobindo Pharma Limited)

NDC Code65862-692-78
Package Description10 BLISTER PACK in 1 CARTON (65862-692-78) / 10 CAPSULE in 1 BLISTER PACK (65862-692-10)
Product NDC65862-692
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameExtended Phenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20150610
Marketing Category NameANDA
Application NumberANDA204309
ManufacturerAurobindo Pharma Limited
Substance NamePHENYTOIN SODIUM
Strength100
Strength Unitmg/1
Pharmacy ClassesAnti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]

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