"65162-999-10" National Drug Code (NDC)

Fosphenytoin Sodium 10 VIAL in 1 CARTON (65162-999-10) / 2 mL in 1 VIAL (65162-999-01)
(Amneal Pharmaceuticals LLC)

NDC Code65162-999-10
Package Description10 VIAL in 1 CARTON (65162-999-10) / 2 mL in 1 VIAL (65162-999-01)
Product NDC65162-999
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFosphenytoin Sodium
Non-Proprietary NameFosphenytoin Sodium
Dosage FormINJECTION
UsageINTRAMUSCULAR; INTRAVENOUS
Start Marketing Date20130517
Marketing Category NameANDA
Application NumberANDA078476
ManufacturerAmneal Pharmaceuticals LLC
Substance NameFOSPHENYTOIN SODIUM
Strength50
Strength Unitmg/mL
Pharmacy ClassesAnti-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]

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