Leflunomide
- Product NDC
- 71335-2256
- 11-digit product format
- 713352256
- Labeler code
- 71335
- Product ID
- 71335-2256_b94989ef-8c6d-403e-8748-df5bbb5c26eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213652
- Marketing category
- ANDA
- Marketing start
- 2021-03-29
- 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 | 205285 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2256-1 | Leflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 101 |
| 71335-2256-2 | Leflunomide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2256 | LEFLUNOMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, 2 package rows | 20240922_acf3efe4-0d70-4718-9c50-789d69ab215d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2256-1 | 71335225601 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2256-1) | 2023-09-25 | No | No | Current |
| 71335-2256-2 | 71335225602 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2256-2) | 2024-09-06 | No | No | Current |