"68382-138-16" National Drug Code (NDC)

Topiramate 90 TABLET, FILM COATED in 1 BOTTLE (68382-138-16)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-138-16
Package Description90 TABLET, FILM COATED in 1 BOTTLE (68382-138-16)
Product NDC68382-138
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20090327
Marketing Category NameANDA
Application NumberANDA078235
ManufacturerZydus Pharmaceuticals USA Inc.
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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