Teriflunomide
- Product NDC
- 69539-316
- 11-digit product format
- 695390316
- Labeler code
- 69539
- Product ID
- 69539-316_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
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1C058IKG3B | TERIFLUNOMIDE | 163451-81-8 | TERIFLUNOMIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69539-316-30 | 69539031630 | 30 TABLET, FILM COATED in 1 BOTTLE (69539-316-30) | | 2023-02-04 | No | No | Historical |
| 69539-316-41 | 69539031641 | 2 BLISTER PACK in 1 CARTON (69539-316-41) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2019-04-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Teriflunomide | MSN LABORATORIES PRIVATE LIMITED | 2023-02-03 | Human Prescription Drug Label | 8 |