Leflunomide
- Product NDC
- 70748-129
- 11-digit product format
- 707480129
- Labeler code
- 70748
- Product ID
- 70748-129_5d28a5cf-ca54-4fcc-a459-2be6ba1afb3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin 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
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 |
|---|
| 70748-129-06 | Leflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70748-129 | LEFLUNOMIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250519_5d48fded-b43b-461a-8488-ca1da5c41a03.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 |
|---|
| 70748-129-06 | 70748012906 | 30 TABLET, FILM COATED in 1 BOTTLE (70748-129-06) | 2020-08-31 | 0000-00-00 | No | No | Current |