"53217-291-02" National Drug Code (NDC)

Topiramate 120 TABLET in 1 BOTTLE (53217-291-02)
(Aidarex Pharmaceuticals LLC)

NDC Code53217-291-02
Package Description120 TABLET in 1 BOTTLE (53217-291-02)
Product NDC53217-291
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET
UsageORAL
Start Marketing Date20140612
Marketing Category NameANDA
Application NumberANDA076343
ManufacturerAidarex Pharmaceuticals LLC
Substance NameTOPIRAMATE
Strength25
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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