"0069-5471-02" National Drug Code (NDC)

NDC Code	0069-5471-02
Package Description	25 VIAL, SINGLE-DOSE in 1 CARTON (0069-5471-02) > 2 mL in 1 VIAL, SINGLE-DOSE (0069-5471-01)
Product NDC	0069-5471
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Cerebyx
Non-Proprietary Name	Fosphenytoin Sodium
Dosage Form	INJECTION, SOLUTION
Usage	INTRAMUSCULAR; INTRAVENOUS
Start Marketing Date	20131028
Marketing Category Name	NDA
Application Number	NDA020450
Manufacturer	Pfizer Laboratories Div Pfizer Inc
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]