Rufinamide
- Product NDC
- 60687-824
- 11-digit product format
- 606870824
- Labeler code
- 60687
- Product ID
- 60687-824_47baf1f7-9edd-d2d7-e063-6294a90a6bfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA207363
- Marketing category
- ANDA
- Marketing start
- 2026-01-06
- Substance
- RUFINAMIDE
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
| Rxcui | 1092357 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-824-08 | Rufinamide | 3 in 1 CASE | SUSPENSION | 3 | | 4 |
| 60687-824-42 | Rufinamide | 10 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 10 | | 4 |
| 60687-824-48 | Rufinamide | 10 in 1 TRAY | SUSPENSION | 10 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-824-08 | 60687082408 | 3 TRAY in 1 CASE (60687-824-08) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-824-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-824-42) | 3 tray | 2026-01-06 | No | No | Historical |
| 60687-824-42 | 60687082442 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | Historical |
| 60687-824-48 | 60687082448 | 10 in 1 TRAY | | | | | Historical |