Rufinamide
- Product NDC
- 69452-223
- 11-digit product format
- 694520223
- Labeler code
- 69452
- Product ID
- 69452-223_3d338656-9665-cc13-e063-6294a90ab433
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rufinamide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA211388
- Marketing category
- ANDA
- Marketing start
- 2018-12-19
- 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 |
|---|
| 69452-223-84 | Rufinamide | 1 in 1 CARTON | SUSPENSION | 1 | | 12 |
| 69452-223-84 | Rufinamide | 460 mL in 1 BOTTLE | SUSPENSION | 460 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-223 | RUFINAMIDE SUSPENSION [BIONPHARMA INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250308_e2ba061a-49f0-4330-b0f0-00f2c3725625.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 |
|---|
| 69452-223-84 | 69452022384 | 1 BOTTLE in 1 CARTON (69452-223-84) / 460 mL in 1 BOTTLE | 1 bottle | 2020-11-06 | 0000-00-00 | No | No | Current |