Banzel
- Product NDC
- 62856-583
- 11-digit product format
- 628560583
- Labeler code
- 62856
- Product ID
- 62856-583_0cc6f13a-0289-45f7-980e-3196d7489d75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rufinamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Eisai Inc.
- Application
- NDA021911
- Marketing category
- NDA
- Marketing start
- 2008-11-14
- Substance
- RUFINAMIDE
- Active strength
- 400 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Banzel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RUFINAMIDE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WFW942PR79 |
| Rxcui | 824295, 824299, 824301, 824303, 1092357, 1092360 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62856-583-14 | Banzel | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 45 |
| 62856-583-52 | Banzel | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 45 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RUFINAMIDE | ACTIVE INGREDIENT | WFW942PR79 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| RUFINAMIDE | ACTIVE MOIETY | WFW942PR79 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | INACTIVE INGREDIENT | K679OBS311 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| ORANGE | INACTIVE INGREDIENT | 5EVU04N5QU | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 24 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62856-583 | BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.] | 45 | Current NDC, Legacy NDC, 2 package rows | 20241116_0a3fa925-1abd-458a-bd57-4ae780a1ef2d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62856-583-14 | 62856058314 | 14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14) | 2018-08-08 | 0000-00-00 | Yes | No | Current |
| 62856-583-52 | 62856058352 | 120 TABLET, FILM COATED in 1 BOTTLE (62856-583-52) | 2008-11-14 | 0000-00-00 | No | No | Current |