teriflunomide
- Product NDC
- 68462-424
- 11-digit product format
- 684620424
- Labeler code
- 68462
- Product ID
- 68462-424_d53d13f1-99cc-4ba3-b1e5-a2781fe6564a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA209663
- Marketing category
- ANDA
- Marketing start
- 2023-01-19
- Substance
- TERIFLUNOMIDE
- Active strength
- 14 mg/1
- Pharmacologic classes
- Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- teriflunomide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERIFLUNOMIDE | 14 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 |
|---|
| 68462-424-15 | teriflunomide | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 4 |
| 68462-424-15 | teriflunomide | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 4 |
| 68462-424-30 | teriflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68462-424-85 | teriflunomide | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 4 |
| 68462-424-85 | teriflunomide | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-424 | TERIFLUNOMIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 2 | Current NDC, 5 package rows | 20240718_cb431ea0-ba0f-4b5d-a50d-f8c050762242.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68462-424-15 | 68462042415 | 2 BLISTER PACK in 1 CARTON (68462-424-15) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2023-01-19 | No | No | Current |
| 68462-424-30 | 68462042430 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-424-30) | | 2023-01-19 | No | No | Current |
| 68462-424-85 | 68462042485 | 1 BLISTER PACK in 1 CARTON (68462-424-85) / 5 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2023-01-19 | No | No | Current |