"67046-0585-3" National Drug Code (NDC)

Phenytoin Sodium 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-0585-3)
(Coupler LLC)

NDC Code67046-0585-3
Package Description30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-0585-3)
Product NDC67046-0585
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhenytoin Sodium
Non-Proprietary NamePhenytoin Sodium
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20260513
Marketing Category NameANDA
Application NumberANDA040684
ManufacturerCoupler LLC
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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