NDC 62856-583
Banzel
Rufinamide
Banzel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Eisai Inc.. The primary component is Rufinamide.
| Product ID | 62856-583_0ab0a8e5-ba46-496a-8f62-be8d95512d2d |
| NDC | 62856-583 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Banzel |
| Generic Name | Rufinamide |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2008-11-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021911 |
| Labeler Name | Eisai Inc. |
| Substance Name | RUFINAMIDE |
| Active Ingredient Strength | 400 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 62856-583-14
14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14)
| Marketing Start Date | 2018-08-08 |
| NDC Exclude Flag | N |
| Sample Package? | Y |
NDC SPL Data Element Entries
NDC 62856-583-52 [62856058352]
Banzel TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021911 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2008-11-14 |
NDC 62856-583-14 [62856058314]
Banzel TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021911 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-08-08 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| RUFINAMIDE | 400 mg/1 |
OpenFDA Data
| SPL SET ID: | 0a3fa925-1abd-458a-bd57-4ae780a1ef2d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Medicade Reported Pricing
62856058352 BANZEL 400 MG TABLET
Pricing Unit: EA | Drug Type:
NDC Crossover Matching brand name "Banzel" or generic name "Rufinamide"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 62856-582 | Banzel | rufinamide |
| 62856-583 | Banzel | rufinamide |
| 62856-584 | Banzel | rufinamide |
| 68180-797 | Banzel | Rufinamide Oral Suspension |
| 0054-0425 | Rufinamide | Rufinamide |
| 0054-0426 | Rufinamide | Rufinamide |
| 0054-0528 | Rufinamide | Rufinamide |
| 0378-2330 | Rufinamide | rufinamide |
| 0378-2331 | Rufinamide | rufinamide |
| 31722-598 | Rufinamide | Rufinamide |
| 31722-599 | Rufinamide | Rufinamide |
| 59651-563 | RUFINAMIDE | RUFINAMIDE |
| 60687-643 | Rufinamide | Rufinamide |
| 67877-673 | Rufinamide | Rufinamide |
| 68180-802 | RUFINAMIDE | rufinamide |
| 68180-803 | RUFINAMIDE | rufinamide |
Trademark Results [Banzel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BANZEL 77334627 3613307 Live/Registered |
Eisai R&D Management Co., Ltd. 2007-11-20 |
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