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"70518-3460-0" National Drug Code (NDC)

Topiramate 30 POUCH in 1 BOX (70518-3460-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3460-1)
(REMEDYREPACK INC.)

NDC Code70518-3460-0
Package Description30 POUCH in 1 BOX (70518-3460-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3460-1)
Product NDC70518-3460
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20220725
Marketing Category NameANDA
Application NumberANDA078462
ManufacturerREMEDYREPACK INC.
Substance NameTOPIRAMATE
Strength50
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]

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