NDC Code | 68382-864-77 |
Package Description | 10 BLISTER PACK in 1 CARTON (68382-864-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-864-30) |
Product NDC | 68382-864 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Topiramate |
Non-Proprietary Name | Topiramate |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20180405 |
Marketing Category Name | ANDA |
Application Number | ANDA207382 |
Manufacturer | Zydus Pharmaceuticals USA Inc. |
Substance Name | TOPIRAMATE |
Strength | 50 |
Strength Unit | mg/1 |
Pharmacy Classes | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] |