NDC Code | 68462-371-05 |
Package Description | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-371-05) |
Product NDC | 68462-371 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Topiramate |
Non-Proprietary Name | Topiramate |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20210201 |
Marketing Category Name | ANDA |
Application Number | ANDA210278 |
Manufacturer | Glenmark Pharmaceuticals Inc., USA |
Substance Name | TOPIRAMATE |
Strength | 200 |
Strength Unit | mg/1 |
Pharmacy Classes | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] |