"68180-561-01" National Drug Code (NDC)

Extended Phenytoin Sodium 100 CAPSULE in 1 BOTTLE (68180-561-01)
(Lupin Pharmaceuticals, Inc.)

NDC Code68180-561-01
Package Description100 CAPSULE in 1 BOTTLE (68180-561-01)
Product NDC68180-561
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameExtended Phenytoin Sodium
Non-Proprietary NameExtended Phenytoin Sodium
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20200201
Marketing Category NameANDA
Application NumberANDA211633
ManufacturerLupin 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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