"68083-461-10" National Drug Code (NDC)

NDC Code	68083-461-10
Package Description	10 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01)
Product NDC	68083-461
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Fosphenytoin Sodium
Non-Proprietary Name	Fosphenytoin Sodium
Dosage Form	INJECTION, SOLUTION
Usage	INTRAMUSCULAR; INTRAVENOUS
Start Marketing Date	20231013
Marketing Category Name	ANDA
Application Number	ANDA214926
Manufacturer	Gland Pharma Limited
Substance Name	FOSPHENYTOIN SODIUM
Strength	50
Strength Unit	mg/mL
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]