LEFLUNOMIDE
- Product NDC
- 50268-477
- 11-digit product format
- 502680477
- Labeler code
- 50268
- Product ID
- 50268-477_47e6f1e5-f12c-c5d1-e063-6294a90a78b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEFLUNOMIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA077090
- Marketing category
- ANDA
- Marketing start
- 2020-09-17
- Substance
- LEFLUNOMIDE
- Active strength
- 10 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 | 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 |
|---|
| 50268-477-11 | LEFLUNOMIDE | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
| 50268-477-15 | LEFLUNOMIDE | 50 in 1 BOX | TABLET | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-477 | LEFLUNOMIDE TABLET [AVPAK] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240110_af836cd0-da42-772e-e053-2995a90ac103.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 |
|---|
| 50268-477-11 | 50268047711 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-477-15 | 50268047715 | 50 BLISTER PACK in 1 BOX (50268-477-15) / 1 TABLET in 1 BLISTER PACK (50268-477-11) | 50 blister pack | 2020-09-17 | 0000-00-00 | No | No | Current |