Teriflunomide
- Product NDC
- 0378-0627
- 11-digit product format
- 003780627
- Labeler code
- 0378
- Product ID
- 0378-0627_1824aae5-58af-43da-8231-435c8f118bc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA209702
- Marketing category
- ANDA
- Marketing start
- 2023-02-14
- Substance
- TERIFLUNOMIDE
- Active strength
- 7 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 | 7 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 |
|---|
| 0378-0627-93 | Teriflunomide | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0627 | TERIFLUNOMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20230215_1824aae5-58af-43da-8231-435c8f118bc0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0378-0627-93 | 00378062793 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0627-93) | 2023-03-31 | No | No | Historical |