"0641-6139-10" National Drug Code (NDC)

Phenytoin Sodium 10 VIAL in 1 CARTON (0641-6139-10) / 5 mL in 1 VIAL (0641-6139-01)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0641-6139-10
Package Description10 VIAL in 1 CARTON (0641-6139-10) / 5 mL in 1 VIAL (0641-6139-01)
Product NDC0641-6139
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormINJECTION
UsageINTRAMUSCULAR; INTRAVENOUS
Start Marketing Date19750716
Marketing Category NameANDA
Application NumberANDA084307
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NamePHENYTOIN 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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