rufinamide
- Product NDC
- 68462-714
- 11-digit product format
- 684620714
- Labeler code
- 68462
- Product ID
- 68462-714_18421d5f-9e93-4abb-8abe-855bab5d243e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rufinamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA205075
- Marketing category
- ANDA
- Marketing start
- 2016-05-16
- Substance
- RUFINAMIDE
- Active strength
- 400 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- rufinamide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RUFINAMIDE | 400 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 |
|---|
| 68462-714-05 | rufinamide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
| 68462-714-08 | rufinamide | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-714 | RUFINAMIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240104_da9ee326-a383-4d46-9d4e-fcc2be3d2680.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 |
|---|
| 68462-714-05 | 68462071405 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-714-05) | 2016-05-16 | 0000-00-00 | No | No | Current |
| 68462-714-08 | 68462071408 | 120 TABLET, FILM COATED in 1 BOTTLE (68462-714-08) | 2016-05-16 | 0000-00-00 | No | No | Current |