"67046-0357-3" National Drug Code (NDC)

Topiramate 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0357-3)
(Coupler LLC)

NDC Code67046-0357-3
Package Description30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0357-3)
Product NDC67046-0357
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20260826
Marketing Category NameANDA
Application NumberANDA078235
ManufacturerCoupler LLC
Substance NameTOPIRAMATE
Strength100
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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