NDC Code | 69680-180-30 |
Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-180-30) |
Product NDC | 69680-180 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Topiramate |
Non-Proprietary Name | Topiramate |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20250407 |
Marketing Category Name | ANDA |
Application Number | ANDA215638 |
Manufacturer | Vitruvias Therapeutics, Inc. |
Substance Name | TOPIRAMATE |
Strength | 150 |
Strength Unit | mg/1 |
Pharmacy Classes | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] |