"10370-365-01" National Drug Code (NDC)

Topiramate 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-365-01)
(ENDO USA, Inc.)

NDC Code10370-365-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-365-01)
Product NDC10370-365
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20230524
Marketing Category NameANDA
Application NumberANDA205976
ManufacturerENDO 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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