RUFINAMIDE
- Product NDC
- 42571-392
- 11-digit product format
- 425710392
- Labeler code
- 42571
- Product ID
- 42571-392_fbdca190-53fc-29e9-e053-6394a90abafe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RUFINAMIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA216688
- Marketing category
- ANDA
- Marketing start
- 2023-07-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-392-12 | RUFINAMIDE | 120 in 1 BOTTLE | TABLET | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-392 | RUFINAMIDE (RUFINAMIDE) TABLET RUFINAMIDE TABLET [MICRO LABS LIMITED] | 1 | Current NDC, 1 package rows | 20230701_12fc41f9-b6a9-4bbd-afbe-5d269f5a42f6.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 |
|---|
| 42571-392-12 | 42571039212 | 120 TABLET in 1 BOTTLE (42571-392-12) | 120 tablet | 2023-07-01 | No | No | Current |