"68382-005-16" National Drug Code (NDC)

Topiramate 90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-16)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-005-16
Package Description90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-16)
Product NDC68382-005
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormCAPSULE, COATED PELLETS
UsageORAL
Start Marketing Date20091014
Marketing Category NameANDA
Application NumberANDA078877
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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