Rufinamide
- Product NDC
- 67877-673
- 11-digit product format
- 678770673
- Labeler code
- 67877
- Product ID
- 67877-673_32782da2-64b5-497c-a620-c5d301c8c592
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA213410
- Marketing category
- ANDA
- Marketing start
- 2021-02-24
- 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
- 2026-12-31
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 |
|---|
| 67877-673-62 | Rufinamide | 460 mL in 1 BOTTLE | SUSPENSION | 460 | | 8 |
| 67877-673-62 | Rufinamide | 1 in 1 CARTON | SUSPENSION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-673 | RUFINAMIDE SUSPENSION [ASCEND LABORATORIES, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240329_a02ca527-bd8f-49ef-89fa-91fac154bffe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-673-62 | 67877067362 | 1 BOTTLE in 1 CARTON (67877-673-62) / 460 mL in 1 BOTTLE | 1 bottle | 2021-02-24 | 0000-00-00 | No | No | Current |