"70518-1967-0" National Drug Code (NDC)

Phenytoin 10 CUP, UNIT-DOSE in 1 BOX (70518-1967-0) / 10 mL in 1 CUP, UNIT-DOSE (70518-1967-1)
(REMEDYREPACK INC.)

NDC Code70518-1967-0
Package Description10 CUP, UNIT-DOSE in 1 BOX (70518-1967-0) / 10 mL in 1 CUP, UNIT-DOSE (70518-1967-1)
Product NDC70518-1967
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin
Non-Proprietary NamePhenytoin
Dosage FormSUSPENSION
UsageORAL
Start Marketing Date20190320
Marketing Category NameANDA
Application NumberANDA040521
ManufacturerREMEDYREPACK INC.
Substance NamePHENYTOIN
Strength125
Strength Unitmg/5mL
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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