| NDC Code | 0832-1072-15 |
|---|
| Package Description | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-1072-15) |
|---|
| Product NDC | 0832-1072 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Topiramate |
|---|
| Non-Proprietary Name | Topiramate |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20140707 |
|---|
| Marketing Category Name | NDA AUTHORIZED GENERIC |
|---|
| Application Number | NDA205122 |
|---|
| Manufacturer | Upsher-Smith Laboratories, LLC |
|---|
| 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] |
|---|