LEFLUNOMIDE
- Product NDC
- 42291-421
- 11-digit product format
- 422910421
- Labeler code
- 42291
- Product ID
- 42291-421_485d0171-db0d-424e-e063-6294a90abcc4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEFLUNOMIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA077090
- Marketing category
- ANDA
- Marketing start
- 2019-06-13
- Substance
- LEFLUNOMIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEFLUNOMIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEFLUNOMIDE | 20 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 |
|---|
| 42291-421-30 | LEFLUNOMIDE | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-421 | LEFLUNOMIDE TABLET [AVKARE] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240110_8b365514-c859-ff93-e053-2a95a90ac698.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 |
|---|
| 42291-421-30 | 42291042130 | 30 TABLET in 1 BOTTLE (42291-421-30) | 30 tablet | 2019-06-13 | 0000-00-00 | No | No | Current |