"0378-6101-91" National Drug Code (NDC)

Topiramate 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6101-91)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-6101-91
Package Description60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6101-91)
Product NDC0378-6101
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20090327
End Marketing Date20170331
Marketing Category NameANDA
Application NumberANDA076314
ManufacturerMylan Pharmaceuticals Inc.
Substance NameTOPIRAMATE
Strength25
Strength Unitmg/1
Pharmacy ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]

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