"0615-8138-39" National Drug Code (NDC)

Topiramate 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8138-39)
(NCS HealthCare of KY, LLC dba Vangard Labs)

NDC Code0615-8138-39
Package Description30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8138-39)
Product NDC0615-8138
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20090327
End Marketing Date20260731
Marketing Category NameANDA
Application NumberANDA077627
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
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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