Leflunomide
- Product NDC
- 46708-436
- 11-digit product format
- 467080436
- Labeler code
- 46708
- Product ID
- 46708-436_aa5c1860-7668-433b-bc17-c6de2b772e0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leflunomide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-436-30 | 2023-02-01 | C162847 | 48780-1 | f386c649-e4f9-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 46708-436-31 | 2023-02-01 | C162847 | 48780-1 | f386c649-e4f9-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 46708-436-60 | 2023-02-01 | C162847 | 48780-1 | f386c649-e4f9-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 46708-436-71 | 2023-02-01 | C162847 | 48780-1 | f386c649-e4f9-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 46708-436-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4f9-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 46708-436-31 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4f9-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 46708-436-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4f9-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 46708-436-71 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4f9-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-436-30 | Leflunomide | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 46708-436-31 | Leflunomide | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 46708-436-60 | Leflunomide | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 46708-436-71 | Leflunomide | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-436 | LEFLUNOMIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230202_f6a4107e-b393-45ed-8e5a-70af5bd53826.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 |
|---|
| 46708-436-30 | 46708043630 | 30 TABLET in 1 BOTTLE (46708-436-30) | 30 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-436-31 | 46708043631 | 100 TABLET in 1 BOTTLE (46708-436-31) | 100 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-436-60 | 46708043660 | 60 TABLET in 1 BOTTLE (46708-436-60) | 60 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-436-71 | 46708043671 | 500 TABLET in 1 BOTTLE (46708-436-71) | 500 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |