Leflunomide
- Product NDC
- 62332-061
- 11-digit product format
- 623320061
- Labeler code
- 62332
- Product ID
- 62332-061_44a1c7ce-ff50-43a8-8593-a0f506eca838
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leflunomide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA091369
- Marketing category
- ANDA
- Marketing start
- 2016-12-01
- 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 |
|---|
| 62332-061-30 | Leflunomide | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 62332-061-31 | Leflunomide | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 62332-061-60 | Leflunomide | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
| 62332-061-71 | Leflunomide | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-061 | LEFLUNOMIDE TABLET [ALEMBIC PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241009_c288d1d3-3fbe-4c34-a28a-923d515809b3.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 |
|---|
| 62332-061-30 | 62332006130 | 30 TABLET in 1 BOTTLE (62332-061-30) | 30 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 62332-061-31 | 62332006131 | 100 TABLET in 1 BOTTLE (62332-061-31) | 100 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 62332-061-60 | 62332006160 | 60 TABLET in 1 BOTTLE (62332-061-60) | 60 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 62332-061-71 | 62332006171 | 500 TABLET in 1 BOTTLE (62332-061-71) | 500 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |