leflunomide
- Product NDC
- 72162-2409
- 11-digit product format
- 721622409
- Labeler code
- 72162
- Product ID
- 72162-2409_2a161440-2216-448b-a0e7-b7264f8a5f92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leflunomide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077086
- Marketing category
- ANDA
- Marketing start
- 2009-10-29
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72162-2409-3 | leflunomide | 30 in 1 BOTTLE | TABLET | 30 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2409 | LEFLUNOMIDE TABLET [BRYANT RANCH PREPACK] | 101 | Current NDC, 1 package rows | 20250313_e76d7767-744f-4e52-956d-e59f7a924826.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2409-3 | 72162240903 | 30 TABLET in 1 BOTTLE (72162-2409-3) | 30 tablet | 2009-10-29 | No | No | Historical |