"70518-0841-3" National Drug Code (NDC)

Phenytoin 50 POUCH in 1 BOX (70518-0841-3) / 1 TABLET, CHEWABLE in 1 POUCH (70518-0841-2)
(REMEDYREPACK INC.)

NDC Code70518-0841-3
Package Description50 POUCH in 1 BOX (70518-0841-3) / 1 TABLET, CHEWABLE in 1 POUCH (70518-0841-2)
Product NDC70518-0841
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin
Non-Proprietary NamePhenytoin
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20171110
Marketing Category NameANDA
Application NumberANDA200565
ManufacturerREMEDYREPACK 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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