Leflunomide
- Product NDC
- 59651-348
- 11-digit product format
- 596510348
- Labeler code
- 59651
- Product ID
- 59651-348_e4a1828b-43bf-42dd-af71-5f9a3d49023c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213652
- Marketing category
- ANDA
- Marketing start
- 2021-03-29
- Substance
- LEFLUNOMIDE
- Active strength
- 10 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 | 10 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 |
|---|
| 59651-348-30 | Leflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-348 | LEFLUNOMIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240823_c358276a-610e-46da-b81a-95c837af205d.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 |
|---|
| 59651-348-30 | 59651034830 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-348-30) | 2021-03-29 | 0000-00-00 | No | No | Current |