"70518-0980-1" National Drug Code (NDC)

NDC Code	70518-0980-1
Package Description	100 POUCH in 1 BOX (70518-0980-1) > 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-0980-2)
Product NDC	70518-0980
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Dilantin
Non-Proprietary Name	Phenytoin Sodium
Dosage Form	CAPSULE, EXTENDED RELEASE
Usage	ORAL
Start Marketing Date	20180122
Marketing Category Name	ANDA
Application Number	ANDA084349
Manufacturer	REMEDYREPACK INC.
Substance Name	PHENYTOIN SODIUM
Strength	30
Strength Unit	mg/1
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]