"58151-118-01" National Drug Code (NDC)

Dilantin 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-118-01)
(Viatris Specialty LLC)

NDC Code58151-118-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-118-01)
Product NDC58151-118
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDilantin
Non-Proprietary NameExtended Phenytoin Sodium
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20250115
Marketing Category NameANDA
Application NumberANDA084349
ManufacturerViatris Specialty LLC
Substance NamePHENYTOIN SODIUM
Strength30
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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