"0378-3850-01" National Drug Code (NDC)

Phenytoin 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3850-01
Package Description100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-01)
Product NDC0378-3850
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin
Non-Proprietary NamePhenytoin
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20121226
End Marketing Date20220228
Marketing Category NameANDA
Application NumberANDA200691
ManufacturerMylan Pharmaceuticals Inc.
Substance NamePHENYTOIN
Strength50
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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