Banzel
- Product NDC
- 75929-098
- 11-digit product format
- 759290098
- Labeler code
- 75929
- Product ID
- 75929-098_3a98e81d-be3a-16f7-e063-6394a90a6207
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rufinamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Pharma Packaging Solutions, LLC dba Tjoapack LLC
- 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 75929-098-12 | 75929009812 | 120 TABLET, FILM COATED in 1 BOTTLE (75929-098-12) | 2008-11-14 | No | No | Current |
| 75929-098-51 | 75929009851 | 120 TABLET, FILM COATED in 1 BOTTLE (75929-098-51) | 2008-11-14 | No | No | Current |