"70518-3353-0" National Drug Code (NDC)

NDC Code	70518-3353-0
Package Description	10 CUP, UNIT-DOSE in 1 BOX (70518-3353-0) / 1 mL in 1 CUP, UNIT-DOSE (70518-3353-1)
Product NDC	70518-3353
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Phenytoin
Non-Proprietary Name	Phenytoin
Dosage Form	SUSPENSION
Usage	ORAL
Start Marketing Date	20220201
Marketing Category Name	ANDA
Application Number	ANDA040610
Manufacturer	REMEDYREPACK INC.
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]