Leflunomide
- Product NDC
- 35573-448
- 11-digit product format
- 355730448
- Labeler code
- 35573
- Product ID
- 35573-448_81914a50-0e77-480d-aec5-2889b31a66d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Burel Pharmaceuticals, LLC
- Application
- ANDA213497
- Marketing category
- ANDA
- Marketing start
- 2022-01-03
- Substance
- LEFLUNOMIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Leflunomide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEFLUNOMIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G162GK9U4W |
| Rxcui | 205284, 205285 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35573-448-30 | Leflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35573-448 | LEFLUNOMIDE TABLET, FILM COATED [BUREL PHARMACEUTICALS, LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250425_fc044417-cd9a-42f6-8a3d-a14e7c2f81a2.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 |
|---|
| 35573-448-30 | 35573044830 | 30 TABLET, FILM COATED in 1 BOTTLE (35573-448-30) | 2022-01-03 | 0000-00-00 | No | No | Current |