"82009-136-05" National Drug Code (NDC)

Topiramate 500 TABLET, FILM COATED in 1 BOTTLE (82009-136-05)
(Quallent Pharmaceuticals Health LLC)

NDC Code82009-136-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (82009-136-05)
Product NDC82009-136
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20230724
Marketing Category NameANDA
Application NumberANDA078235
ManufacturerQuallent Pharmaceuticals Health LLC
Substance NameTOPIRAMATE
Strength50
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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