Leflunomide
- Product NDC
- 63629-9728
- 11-digit product format
- 636299728
- Labeler code
- 63629
- Product ID
- 63629-9728_8dc1df53-82db-4ea2-a0d7-0f6add8b5bda
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213652
- Marketing category
- ANDA
- Marketing start
- 2021-03-29
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-9728-1 | Leflunomide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-9728 | LEFLUNOMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, 1 package rows | 20241004_e85c4eed-794c-409b-aed5-3c857b14b1fb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-9728-1 | 63629972801 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-9728-1) | 2023-08-11 | No | No | Historical |