"0615-8139-39" National Drug Code (NDC)

Topiramate 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8139-39)
(NCS HealthCare of KY, LLC dba Vangard Labs)

NDC Code0615-8139-39
Package Description30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8139-39)
Product NDC0615-8139
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20090327
Marketing Category NameANDA
Application NumberANDA077627
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
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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