"58151-115-35" National Drug Code (NDC)

NDC Code	58151-115-35
Package Description	1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC
Product NDC	58151-115
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Dilantin-125
Non-Proprietary Name	Phenytoin
Dosage Form	SUSPENSION
Usage	ORAL
Start Marketing Date	20240419
Marketing Category Name	NDA
Application Number	NDA008762
Manufacturer	Viatris Specialty LLC
Substance Name	PHENYTOIN
Strength	125
Strength Unit	mg/5mL
Pharmacy Classes	Anti-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]