"53002-1501-0" National Drug Code (NDC)

Phenytoin Sodium 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1501-0)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-1501-0
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1501-0)
Product NDC53002-1501
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20061212
Marketing Category NameANDA
Application NumberANDA040621
ManufacturerRPK Pharmaceuticals, Inc.
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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