Rufinamide
- Product NDC
- 0378-2330
- 11-digit product format
- 003782330
- Labeler code
- 0378
- Product ID
- 0378-2330_9e06d86c-b2bd-4afa-95f8-58622d83fd65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rufinamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205095
- Marketing category
- ANDA
- Marketing start
- 2021-06-01
- Marketing end
- 0000-00-00
- Substance
- RUFINAMIDE
- Active strength
- 200 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-2330 | RUFINAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | Legacy NDC | 20250101_c49c9768-67dc-4ea6-b880-e3cf17f68ec6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-2330-78 | 00378233078 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2330-78) | 2021-06-01 | 0000-00-00 | No | No | Current |