"68180-561-03" National Drug Code (NDC)

NDC Code	68180-561-03
Package Description	1000 CAPSULE in 1 BOTTLE (68180-561-03)
Product NDC	68180-561
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Extended Phenytoin Sodium
Non-Proprietary Name	Extended Phenytoin Sodium
Dosage Form	CAPSULE
Usage	ORAL
Start Marketing Date	20200201
Marketing Category Name	ANDA
Application Number	ANDA211633
Manufacturer	Lupin Pharmaceuticals, Inc.
Substance Name	PHENYTOIN SODIUM
Strength	100
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]