NDC Code | 0245-1071-90 |
Package Description | 1 BOTTLE in 1 CARTON (0245-1071-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE |
Product NDC | 0245-1071 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Qudexy |
Proprietary Name Suffix | Xr |
Non-Proprietary Name | Topiramate |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20140411 |
Marketing Category Name | NDA |
Application Number | NDA205122 |
Manufacturer | Upsher-Smith Laboratories, LLC |
Substance Name | TOPIRAMATE |
Strength | 25 |
Strength Unit | mg/1 |
Pharmacy Classes | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] |