Leflunomide
- Product NDC
- 68071-3763
- 11-digit product format
- 680713763
- Labeler code
- 68071
- Product ID
- 68071-3763_2b5ca657-3fa5-8704-e063-6394a90a9f26
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA211863
- Marketing category
- ANDA
- Marketing start
- 2020-08-31
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| G162GK9U4W | LEFLUNOMIDE | 75706-12-6 | LEFLUNOMIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3763-9 | 68071376309 | 1 BOTTLE in 1 CARTON (68071-3763-9) / 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-01-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Leflunomide | NuCare Pharmaceuticals, Inc. | 2025-01-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |