Rufinamide
- Product NDC
- 72205-038
- 11-digit product format
- 722050038
- Labeler code
- 72205
- Product ID
- 72205-038_924ffdf9-ce5f-4989-9a43-78a03ba3eaed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA214817
- Marketing category
- ANDA
- Marketing start
- 2025-04-15
- Substance
- RUFINAMIDE
- Active strength
- 40 mg/mL
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RUFINAMIDE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WFW942PR79 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72205-038-77 | Rufinamide | 460 mL in 1 BOTTLE | SUSPENSION | 460 | | 1 |
| 72205-038-77 | Rufinamide | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72205-038 | RUFINAMIDE SUSPENSION [NOVADOZ PHARMACEUTICALS LLC] | 1 | Current NDC, 2 package rows | 20250423_924ffdf9-ce5f-4989-9a43-78a03ba3eaed.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-038-77 | 72205003877 | 1 BOTTLE in 1 CARTON (72205-038-77) / 460 mL in 1 BOTTLE | 1 bottle | 2025-06-01 | No | No | Current |