leflunomide
- Product NDC
- 70771-1491
- 11-digit product format
- 707711491
- Labeler code
- 70771
- Product ID
- 70771-1491_e96c4125-a2bf-420c-8ffe-6d7ddb7dd645
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA212308
- Marketing category
- ANDA
- Marketing start
- 2019-04-26
- 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 |
|---|
| 70771-1491-1 | leflunomide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 70771-1491-3 | leflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 70771-1491-5 | leflunomide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1491 | LEFLUNOMIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240815_c66cacd1-93f7-483a-a2fc-aad53d5342b0.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 |
|---|
| 70771-1491-1 | 70771149101 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1491-1) | 2019-04-26 | 0000-00-00 | No | No | Current |
| 70771-1491-3 | 70771149103 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1491-3) | 2019-04-26 | 0000-00-00 | No | No | Current |
| 70771-1491-5 | 70771149105 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1491-5) | 2019-04-26 | 0000-00-00 | No | No | Current |