Rufinamide
- Product NDC
- 68180-797
- 11-digit product format
- 681800797
- Labeler code
- 68180
- Product ID
- 68180-797_47c9752b-a06d-46af-a029-9213e2474378
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA213457
- Marketing category
- ANDA
- Marketing start
- 2023-06-22
- 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 |
|---|
| 68180-797-01 | Rufinamide | 1 in 1 CARTON | SUSPENSION | 1 | | 12 |
| 68180-797-01 | Rufinamide | 460 mL in 1 BOTTLE | SUSPENSION | 460 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-797 | RUFINAMIDE SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250515_1e671632-d5bd-499a-ba06-0d1dc0d99622.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 |
|---|
| 68180-797-01 | 68180079701 | 1 BOTTLE in 1 CARTON (68180-797-01) / 460 mL in 1 BOTTLE | 1 bottle | 2023-06-22 | 0000-00-00 | No | No | Current |