Rufinamide
- Product NDC
- 31722-688
- 11-digit product format
- 317220688
- Labeler code
- 31722
- Product ID
- 31722-688_0d914e03-3610-c662-e063-6294a90a5430
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA216841
- Marketing category
- ANDA
- Marketing start
- 2023-12-05
- 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 |
|---|
| 31722-688-46 | Rufinamide | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
| 31722-688-46 | Rufinamide | 460 mL in 1 BOTTLE | SUSPENSION | 460 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-688 | RUFINAMIDE SUSPENSION [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20231229_1c2f9bf2-1711-4975-af02-32614db25add.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 |
|---|
| 31722-688-46 | 31722068846 | 1 BOTTLE in 1 CARTON (31722-688-46) / 460 mL in 1 BOTTLE | 1 bottle | 2023-12-05 | No | No | Historical |