"71610-479-70" National Drug Code (NDC)

Extended Phenytoin Sodium 120 CAPSULE in 1 BOTTLE (71610-479-70)
(Aphena Pharma Solutions - Tennessee, LLC)

NDC Code71610-479-70
Package Description120 CAPSULE in 1 BOTTLE (71610-479-70)
Product NDC71610-479
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameExtended Phenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20200825
Marketing Category NameANDA
Application NumberANDA040765
ManufacturerAphena Pharma Solutions - Tennessee, LLC
Substance NamePHENYTOIN SODIUM
Strength100
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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