"83008-012-27" National Drug Code (NDC)

Topiramate 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (83008-012-27)
(Quality Care Products, LLC)

NDC Code83008-012-27
Package Description270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (83008-012-27)
Product NDC83008-012
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20230323
Marketing Category NameANDA
Application NumberANDA090162
ManufacturerQuality Care Products, LLC
Substance NameTOPIRAMATE
Strength25
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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