"68382-864-77" National Drug Code (NDC)

Topiramate 10 BLISTER PACK in 1 CARTON (68382-864-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-864-30)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-864-77
Package Description10 BLISTER PACK in 1 CARTON (68382-864-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-864-30)
Product NDC68382-864
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
Strength50
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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