| NDC Code | 0378-4504-05 |
| Package Description | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4504-05) |
| Product NDC | 0378-4504 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Dalfampridine |
| Non-Proprietary Name | Dalfampridine |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20220531 |
| Marketing Category Name | ANDA |
| Application Number | ANDA206858 |
| Manufacturer | Mylan Pharmaceuticals Inc. |
| Substance Name | DALFAMPRIDINE |
| Strength | 10 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC] |