Rufinamide
- Product NDC
- 0054-0426
- 11-digit product format
- 000540426
- Labeler code
- 0054
- Product ID
- 0054-0426_72348f03-413e-4d00-be89-00c719af669b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA204988
- Marketing category
- ANDA
- Marketing start
- 2021-05-30
- 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
- Rufinamide
- 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, 824301 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0426-13 | Rufinamide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 0054-0426-23 | Rufinamide | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0426 | RUFINAMIDE TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20221021_56316809-6e73-4717-990b-fc84bf6bf433.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 |
|---|
| 0054-0426-13 | 00054042613 | 30 TABLET, FILM COATED in 1 BOTTLE (0054-0426-13) | 2021-05-30 | 0000-00-00 | No | No | Current |
| 0054-0426-23 | 00054042623 | 120 TABLET, FILM COATED in 1 BOTTLE (0054-0426-23) | 2021-05-30 | 0000-00-00 | No | No | Current |