"12634-083-09" National Drug Code (NDC)

Topiramate 35 TABLET, FILM COATED in 1 BOTTLE (12634-083-09)
(Apotheca Inc.)

NDC Code12634-083-09
Package Description35 TABLET, FILM COATED in 1 BOTTLE (12634-083-09)
Product NDC12634-083
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20141215
Marketing Category NameANDA
Application NumberANDA090278
ManufacturerApotheca 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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