NDC 0378-4504
dalfampridine
Dalfampridine
dalfampridine is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Dalfampridine.
| Product ID | 0378-4504_0f8d5e1e-9f72-459f-9fbf-fd38c7ece962 |
| NDC | 0378-4504 |
| Product Type | Human Prescription Drug |
| Proprietary Name | dalfampridine |
| Generic Name | Dalfampridine |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-05-31 |
| Marketing Category | ANDA / |
| Application Number | ANDA206858 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | DALFAMPRIDINE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |