Teriflunomide
- Product NDC
- 69539-032
- 11-digit product format
- 695390032
- Labeler code
- 69539
- Product ID
- 69539-032_3b178225-b3ba-4c9f-bde6-a5e076697980
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- MSN LABORATORIES PRIVATE LIMITED
- Application
- ANDA209623
- Marketing category
- ANDA
- Marketing start
- 2019-04-24
- 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 |
|---|
| 69539-032-41 | Teriflunomide | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 8 |
| 69539-032-41 | Teriflunomide | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69539-032 | TERIFLUNOMIDE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED] | 8 | Current NDC, Legacy NDC, 2 package rows | 20230208_63ba28ef-5055-461a-99ef-c49e8ece4b54.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69539-032-41 | 69539003241 | 2 BLISTER PACK in 1 CARTON (69539-032-41) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2019-04-24 | 0000-00-00 | No | No | Current |