Rufinamide
- Product NDC
- 0054-0528
- 11-digit product format
- 000540528
- Labeler code
- 0054
- Product ID
- 0054-0528_eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA207363
- Marketing category
- ANDA
- Marketing start
- 2020-11-01
- Substance
- RUFINAMIDE
- Active strength
- 40 mg/mL
- 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 | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WFW942PR79 |
| Rxcui | 1092357 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0528-63 | Rufinamide | 1 in 1 CARTON | SUSPENSION | 1 | | 5 |
| 0054-0528-63 | Rufinamide | 460 mL in 1 BOTTLE | SUSPENSION | 460 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0528 | RUFINAMIDE SUSPENSION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220512_8ef75997-06f6-441f-8320-a23bc13ca2d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0528-63 | 00054052863 | 1 BOTTLE in 1 CARTON (0054-0528-63) / 460 mL in 1 BOTTLE | 1 bottle | 2020-11-01 | 0000-00-00 | No | No | Current |