"80425-0398-2" National Drug Code (NDC)

Topiramate 60 TABLET, FILM COATED in 1 BOTTLE (80425-0398-2)
(Advanced Rx of Tennessee, LLC)

NDC Code80425-0398-2
Package Description60 TABLET, FILM COATED in 1 BOTTLE (80425-0398-2)
Product NDC80425-0398
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20240604
Marketing Category NameANDA
Application NumberANDA078235
ManufacturerAdvanced Rx of Tennessee, LLC
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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