"49349-495-02" National Drug Code (NDC)

Dilantin 30 TABLET, CHEWABLE in 1 BLISTER PACK (49349-495-02)
(REMEDYREPACK INC.)

NDC Code49349-495-02
Package Description30 TABLET, CHEWABLE in 1 BLISTER PACK (49349-495-02)
Product NDC49349-495
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDilantin
Non-Proprietary NamePhenytoin
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20110818
Marketing Category NameANDA
Application NumberANDA084427
ManufacturerREMEDYREPACK INC.
Substance NamePHENYTOIN
Strength50
Strength Unitmg/1
Pharmacy ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]

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