"50268-719-13" National Drug Code (NDC)

Phenytoin Sodium 30 BLISTER PACK in 1 CARTON (50268-719-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-719-11)
(AvPAK)

NDC Code50268-719-13
Package Description30 BLISTER PACK in 1 CARTON (50268-719-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-719-11)
Product NDC50268-719
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20260303
Marketing Category NameANDA
Application NumberANDA040684
ManufacturerAvPAK
Substance NamePHENYTOIN SODIUM
Strength100
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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