"52584-317-01" National Drug Code (NDC)

Phenytoin Sodium 1 AMPULE in 1 BAG (52584-317-01) > 2 mL in 1 AMPULE
(General Injectables & Vaccines, Inc)

NDC Code52584-317-01
Package Description1 AMPULE in 1 BAG (52584-317-01) > 2 mL in 1 AMPULE
Product NDC52584-317
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormINJECTION, SOLUTION
UsageINTRAMUSCULAR; INTRAVENOUS
Start Marketing Date20100801
Marketing Category NameANDA
Application NumberANDA089521
ManufacturerGeneral Injectables & Vaccines, Inc
Substance NamePHENYTOIN SODIUM
Strength50
Strength Unitmg/mL
Pharmacy ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]

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