LACOSAMIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Lacosamide.
| Product ID | 51991-349_21d8300b-b6d1-4a99-ac67-7fa92c1cc809 |
| NDC | 51991-349 |
| Product Type | Human Prescription Drug |
| Proprietary Name | LACOSAMIDE |
| Generic Name | Lacosamide |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-03-18 |
| Marketing Category | ANDA / |
| Application Number | ANDA204921 |
| Labeler Name | Breckenridge Pharmaceutical, Inc. |
| Substance Name | LACOSAMIDE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | CV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-03-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204921 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-06-15 |
| Marketing End Date | 2016-06-16 |
| Marketing Category | ANDA |
| Application Number | ANDA204921 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-06-15 |
| Marketing End Date | 2016-06-16 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0121-0992 | Lacosamide | Lacosamide |
| 0121-1984 | Lacosamide | Lacosamide |
| 0121-2976 | Lacosamide | Lacosamide |
| 0121-3968 | Lacosamide | Lacosamide |
| 63850-0055 | Lacosamide | Lacosamide |
| 63850-0053 | Lacosamide | Lacosamide |
| 63850-0054 | Lacosamide | Lacosamide |
| 63850-0056 | Lacosamide | Lacosamide |
| 65162-912 | Lacosamide | Lacosamide |
| 0131-1810 | Vimpat | lacosamide |
| 0131-2470 | Vimpat | lacosamide |
| 0131-2477 | Vimpat | lacosamide |
| 0131-2478 | Vimpat | lacosamide |
| 0131-2479 | Vimpat | lacosamide |