"0615-8424-39" National Drug Code (NDC)

Phenytoin Infatabs 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8424-39)
(NCS HealthCare of KY, LLC dba Vangard Labs)

NDC Code0615-8424-39
Package Description30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8424-39)
Product NDC0615-8424
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin Infatabs
Non-Proprietary NamePhenytoin
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20211123
Marketing Category NameANDA
Application NumberANDA084427
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
Substance NamePHENYTOIN
Strength50
Strength Unitmg/1
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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