"72865-316-10" National Drug Code (NDC)

Topiramate 1000 TABLET in 1 BOTTLE (72865-316-10)
(XLCare Pharmaceuticals, Inc.)

NDC Code72865-316-10
Package Description1000 TABLET in 1 BOTTLE (72865-316-10)
Product NDC72865-316
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormTABLET
UsageORAL
Start Marketing Date20250710
Marketing Category NameANDA
Application NumberANDA215414
ManufacturerXLCare Pharmaceuticals, Inc.
Substance NameTOPIRAMATE
Strength200
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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