Dalfampridine is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Dalfampridine.
| Product ID | 16729-292_7637e638-5933-a9fe-e053-2991aa0ab11d |
| NDC | 16729-292 |
| 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 | 2018-09-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206863 |
| Labeler Name | Accord Healthcare Inc. |
| Substance Name | DALFAMPRIDINE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Potassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-09-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206863 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-18 |
| Ingredient | Strength |
|---|---|
| DALFAMPRIDINE | 10 mg/1 |
| SPL SET ID: | 354a97e8-35c8-418b-91b2-9e8e066cec65 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0479 | Dalfampridine | Dalfampridine |
| 0378-0509 | dalfampridine | dalfampridine |
| 0378-4504 | dalfampridine | dalfampridine |
| 0591-2533 | Dalfampridine | Dalfampridine |
| 16729-292 | Dalfampridine | Dalfampridine |
| 42571-275 | DALFAMPRIDINE | DALFAMPRIDINE |
| 51407-246 | Dalfampridine | Dalfampridine |
| 62756-429 | Dalfampridine | Dalfampridine |
| 63629-9450 | Dalfampridine | Dalfampridine |
| 65862-863 | DALFAMPRIDINE | DALFAMPRIDINE |
| 67877-444 | Dalfampridine | Dalfampridine |
| 10144-427 | AMPYRA | Dalfampridine |