Leflunomide
- Product NDC
- 68258-2992
- 11-digit product format
- 682582992
- Labeler code
- 68258
- Product ID
- 68258-2992_be0d579b-3b66-4227-b532-b0ee186a24ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leflunomide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA077086
- Marketing category
- ANDA
- Marketing start
- 2009-10-29
- Marketing end
- 0000-00-00
- Substance
- LEFLUNOMIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Antirheumatic Agent [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68258-2992-3 | Leflunomide | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| 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 |
|---|
| 68258-2992 | LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 1 package rows | 20131017_2fcef74c-2df9-4b16-b2f6-82c25957a680.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68258-2992-3 | 68258299203 | 30 in 1 BOTTLE | Historical |