"70518-0231-0" National Drug Code (NDC)

Extended Phenytoin Sodium 30 CAPSULE in 1 BLISTER PACK (70518-0231-0)
(REMEDYREPACK INC.)

NDC Code70518-0231-0
Package Description30 CAPSULE in 1 BLISTER PACK (70518-0231-0)
Product NDC70518-0231
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameExtended Phenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20170216
Marketing Category NameANDA
Application NumberANDA040765
ManufacturerREMEDYREPACK INC.
Substance NamePHENYTOIN SODIUM
Strength100
Strength Unitmg/1
Pharmacy ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]

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