Rufinamide
- Product NDC
- 72603-261
- 11-digit product format
- 726030261
- Labeler code
- 72603
- Product ID
- 72603-261_1ccfda8b-0fa1-6b4a-e063-6294a90a15ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA216841
- Marketing category
- ANDA
- Marketing start
- 2024-08-01
- 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 |
|---|
| 72603-261-01 | Rufinamide | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
| 72603-261-01 | 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 |
|---|
| 72603-261 | RUFINAMIDE (RUFINAMIDE) SUSPENSION [NORTHSTAR RXLLC] | 1 | Current NDC, 2 package rows | 20240802_b682021c-74c3-4cc8-84af-acd94438397a.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 |
|---|
| 72603-261-01 | 72603026101 | 1 BOTTLE in 1 CARTON (72603-261-01) / 460 mL in 1 BOTTLE | 1 bottle | 2024-08-01 | No | No | Current |