RUFINAMIDE
- Product NDC
- 68180-804
- 11-digit product format
- 681800804
- Labeler code
- 68180
- Product ID
- 68180-804_3db88bc9-af10-4a67-86c5-9f034fa4db9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rufinamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA204964
- Marketing category
- ANDA
- Marketing start
- 2022-11-28
- Substance
- RUFINAMIDE
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WFW942PR79 |
| Rxcui | 824295, 824301, 2612668 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-804-16 | RUFINAMIDE | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-804 | RUFINAMIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20231208_2c2c8d41-1ae4-453a-b628-954ee0b3be5c.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 |
|---|
| 68180-804-16 | 68180080416 | 120 TABLET, FILM COATED in 1 BOTTLE (68180-804-16) | 2022-11-28 | 0000-00-00 | No | No | Current |