"0378-1560-01" National Drug Code (NDC)

Phenytoin Sodium 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1560-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1560-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1560-01)
Product NDC0378-1560
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date19990105
End Marketing Date20230228
Marketing Category NameANDA
Application NumberANDA040298
ManufacturerMylan Pharmaceuticals Inc.
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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