leflunomide
- Product NDC
- 23155-043
- 11-digit product format
- 231550043
- Labeler code
- 23155
- Product ID
- 23155-043_bb1ee142-184a-4202-9513-e2036758fa6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leflunomide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA077086
- Marketing category
- ANDA
- Marketing start
- 2009-10-29
- 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 |
|---|
| 23155-043-03 | leflunomide | 30 in 1 BOTTLE | TABLET | 30 | | 14 |
| 23155-043-05 | leflunomide | 500 in 1 BOTTLE | TABLET | 500 | | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-043 | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20220430_40dd071a-d07f-452f-bf1a-2a23b9d22ca4.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 |
|---|
| 23155-043-03 | 23155004303 | 30 TABLET in 1 BOTTLE (23155-043-03) | 30 tablet | 2009-10-29 | 0000-00-00 | No | No | Current |
| 23155-043-05 | 23155004305 | 500 TABLET in 1 BOTTLE (23155-043-05) | 500 tablet | 2009-10-29 | 0000-00-00 | No | No | Current |