"76282-280-60" National Drug Code (NDC)

Topiramate 60 TABLET in 1 BOTTLE (76282-280-60)
(EXELAN PHARMACEUTICALS INC.)

NDC Code76282-280-60
Package Description60 TABLET in 1 BOTTLE (76282-280-60)
Product NDC76282-280
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET
UsageORAL
Start Marketing Date20200907
Marketing Category NameANDA
Application NumberANDA079162
ManufacturerEXELAN PHARMACEUTICALS INC.
Substance NameTOPIRAMATE
Strength100
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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