Rufinamide
- Product NDC
- 31722-598
- 11-digit product format
- 317220598
- Labeler code
- 31722
- Product ID
- 31722-598_c3c611a2-394b-4427-e053-2a95a90a433f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204993
- Marketing category
- ANDA
- Marketing start
- 2021-05-11
- 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 |
|---|
| 31722-598-12 | Rufinamide | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1 |
| 31722-598-30 | Rufinamide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-598 | RUFINAMIDE (RUFINAMIDE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210603_afe24968-e078-46d6-a776-b2608734e03e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-598-12 | 31722059812 | 120 TABLET, FILM COATED in 1 BOTTLE (31722-598-12) | 2021-05-11 | 0000-00-00 | No | No | Current |
| 31722-598-30 | 31722059830 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-598-30) | 2021-05-11 | 0000-00-00 | No | No | Current |