Rufinamide
- Product NDC
- 59651-616
- 11-digit product format
- 596510616
- Labeler code
- 59651
- Product ID
- 59651-616_96d61d77-4de0-4c57-997d-014010177a86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rufinamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA217230
- Marketing category
- ANDA
- Marketing start
- 2023-06-16
- Substance
- RUFINAMIDE
- Active strength
- 200 mg/1
- 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WFW942PR79 |
| Rxcui | 824295, 824301 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-616-08 | Rufinamide | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-616 | RUFINAMIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 1 package rows | 20230623_d9ffc833-d902-41cb-8e8e-6bbba8e65b9e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-616-08 | 59651061608 | 120 TABLET, FILM COATED in 1 BOTTLE (59651-616-08) | 2023-06-16 | No | No | Current |