TERIFLUNOMIDE
- Product NDC
- 68254-5009
- 11-digit product format
- 682545009
- Labeler code
- 68254
- Product ID
- 68254-5009_ebb5a19c-6889-4d12-b9fd-b7dea06a52d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TERIFLUNOMIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CONCORD BIOTECH LIMITED
- Application
- ANDA218663
- Marketing category
- ANDA
- Marketing start
- 2025-07-07
- 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 |
|---|
| 68254-5009-1 | TERIFLUNOMIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68254-5009-1 | 68254500901 | 30 TABLET, FILM COATED in 1 BOTTLE (68254-5009-1) | 2025-07-07 | No | No | Historical |