Leflunomide
- Product NDC
- 62135-794
- 11-digit product format
- 621350794
- Labeler code
- 62135
- Product ID
- 62135-794_46268884-f963-f34a-e063-6294a90aa8d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leflunomide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA077086
- Marketing category
- ANDA
- Marketing start
- 2009-10-29
- Substance
- LEFLUNOMIDE
- Active strength
- 20 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 | 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 |
|---|
| 62135-794-30 | Leflunomide | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-794-30 | 62135079430 | 30 TABLET in 1 BOTTLE (62135-794-30) | 30 tablet | 2023-10-26 | No | No | Historical |