"70518-4149-0" National Drug Code (NDC)

Phenytoin Infatabs 100 POUCH in 1 BOX (70518-4149-0) / 1 TABLET, CHEWABLE in 1 POUCH (70518-4149-1)
(REMEDYREPACK INC.)

NDC Code70518-4149-0
Package Description100 POUCH in 1 BOX (70518-4149-0) / 1 TABLET, CHEWABLE in 1 POUCH (70518-4149-1)
Product NDC70518-4149
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin Infatabs
Non-Proprietary NamePhenytoin
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20240726
Marketing Category NameANDA
Application NumberANDA084427
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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