"42549-621-12" National Drug Code (NDC)

Topiramate 120 TABLET, FILM COATED in 1 BOTTLE (42549-621-12)
(STAT Rx USA LLC)

NDC Code42549-621-12
Package Description120 TABLET, FILM COATED in 1 BOTTLE (42549-621-12)
Product NDC42549-621
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20090327
Marketing Category NameANDA
Application NumberANDA090278
ManufacturerSTAT Rx USA LLC
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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