leflunomide
- Product NDC
- 23155-044
- 11-digit product format
- 231550044
- Labeler code
- 23155
- Product ID
- 23155-044_bb1ee142-184a-4202-9513-e2036758fa6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leflunomide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- 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 |
|---|
| 23155-044-03 | leflunomide | 30 in 1 BOTTLE | TABLET | 30 | | 14 |
| 23155-044-05 | leflunomide | 500 in 1 BOTTLE | TABLET | 500 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEFLUNOMIDE | ACTIVE INGREDIENT | G162GK9U4W | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC] | 6 | |
| LEFLUNOMIDE | ACTIVE MOIETY | G162GK9U4W | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC] | 6 | |
| LEFLUNOMIDE | ACTIVE INGREDIENT | G162GK9U4W | LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| LEFLUNOMIDE | ACTIVE MOIETY | G162GK9U4W | LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-044 | LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20220430_40dd071a-d07f-452f-bf1a-2a23b9d22ca4.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 |
|---|
| 23155-044-03 | 23155004403 | 30 TABLET in 1 BOTTLE (23155-044-03) | 30 tablet | 2009-10-29 | 0000-00-00 | No | No | Current |
| 23155-044-05 | 23155004405 | 500 TABLET in 1 BOTTLE (23155-044-05) | 500 tablet | 2009-10-29 | 0000-00-00 | No | No | Current |