Teriflunomide
- Product NDC
- 0480-3156
- 11-digit product format
- 004803156
- Labeler code
- 0480
- Product ID
- 0480-3156_3196d973-fb6b-4da7-8f23-1f8e4f44bcf7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA209700
- Marketing category
- ANDA
- Marketing start
- 2023-03-13
- Substance
- TERIFLUNOMIDE
- Active strength
- 14 mg/1
- Pharmacologic classes
- Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Teriflunomide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERIFLUNOMIDE | 14 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1C058IKG3B |
| Rxcui | 1310525, 1310533 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-3156-56 | Teriflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-3156 | TERIFLUNOMIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] | 4 | Current NDC, 1 package rows | 20241122_c424959d-00c9-4e76-aba6-cc7464d8e903.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-3156-56 | 00480315656 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-3156-56) | 2023-03-13 | No | No | Historical |