"0121-0892-50" National Drug Code (NDC)

Phenytoin 5 TRAY in 1 CASE (0121-0892-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (0121-0892-63)
(PAI Holdings, LLC)

NDC Code0121-0892-50
Package Description5 TRAY in 1 CASE (0121-0892-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (0121-0892-63)
Product NDC0121-0892
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin
Non-Proprietary NamePhenytoin
Dosage FormSUSPENSION
UsageORAL
Start Marketing Date20040408
Marketing Category NameANDA
Application NumberANDA040521
ManufacturerPAI Holdings, LLC
Substance NamePHENYTOIN
Strength125
Strength Unitmg/5mL
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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