"68382-769-01" National Drug Code (NDC)

Topiramate 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-01)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-769-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-01)
Product NDC68382-769
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20180405
Marketing Category NameANDA
Application NumberANDA207382
ManufacturerZydus Pharmaceuticals USA Inc.
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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