Teriflunomide
- Product NDC
- 16729-399
- 11-digit product format
- 167290399
- Labeler code
- 16729
- Product ID
- 16729-399_44e80dd3-d2da-1271-e063-6394a90aa672
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA209690
- Marketing category
- ANDA
- Marketing start
- 2023-03-13
- 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 |
|---|
| 16729-399-09 | Teriflunomide | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 5 |
| 16729-399-10 | Teriflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 16729-399-15 | Teriflunomide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
| 16729-399-76 | Teriflunomide | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 16729-399-76 | Teriflunomide | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-399 | TERIFLUNOMIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 4 | Current NDC, 5 package rows | 20240216_246d42e5-5418-42ba-aff9-ae399b166c69.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 16729-399-09 | 16729039909 | 28 in 1 BOTTLE | | | | Historical |
| 16729-399-10 | 16729039910 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-399-10) | 2023-03-13 | No | No | Current |
| 16729-399-15 | 16729039915 | 90 in 1 BOTTLE | | | | Historical |
| 16729-399-76 | 16729039976 | 1 in 1 CARTON | | | | Historical |