"0832-0708-15" National Drug Code (NDC)

Topiramate 500 TABLET, COATED in 1 BOTTLE (0832-0708-15)
(Upsher-Smith Laboratories, Inc.)

NDC Code0832-0708-15
Package Description500 TABLET, COATED in 1 BOTTLE (0832-0708-15)
Product NDC0832-0708
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20101117
Marketing Category NameANDA
Application NumberANDA078499
ManufacturerUpsher-Smith Laboratories, Inc.
Substance NameTOPIRAMATE
Strength50
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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