"0378-6103-05" National Drug Code (NDC)

Topiramate 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6103-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-6103-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6103-05)
Product NDC0378-6103
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20121212
Marketing Category NameANDA
Application NumberANDA076314
ManufacturerMylan Pharmaceuticals Inc.
Substance NameTOPIRAMATE
Strength100
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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