"63323-403-10" National Drug Code (NDC)

Fosphenytoin 10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04)
(Fresenius Kabi USA, LLC)

NDC Code63323-403-10
Package Description10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04)
Product NDC63323-403
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFosphenytoin
Non-Proprietary NameFosphenytoin Sodium
Dosage FormINJECTION, SOLUTION
UsageINTRAMUSCULAR; INTRAVENOUS
Start Marketing Date20091214
Marketing Category NameANDA
Application NumberANDA078052
ManufacturerFresenius Kabi USA, 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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