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"70518-1937-3" National Drug Code (NDC)

Topiramate 100 POUCH in 1 BOX (70518-1937-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-1937-4)
(REMEDYREPACK INC.)

NDC Code70518-1937-3
Package Description100 POUCH in 1 BOX (70518-1937-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-1937-4)
Product NDC70518-1937
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20190306
Marketing Category NameANDA
Application NumberANDA078235
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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