"43353-131-94" National Drug Code (NDC)

Dilantin 360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-131-94)
(Aphena Pharma Solutions - Tennessee, Inc.)

NDC Code43353-131-94
Package Description360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-131-94)
Product NDC43353-131
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDilantin
Non-Proprietary NamePhenytoin Sodium
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date19760827
Marketing Category NameANDA
Application NumberANDA084349
ManufacturerAphena Pharma Solutions - Tennessee, 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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