TERIFLUNOMIDE
- Product NDC
- 62332-313
- 11-digit product format
- 623320313
- Labeler code
- 62332
- Product ID
- 62332-313_95e1ed70-9c5b-4bad-a26e-b33cd3f9b7ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TERIFLUNOMIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA209572
- Marketing category
- ANDA
- Marketing start
- 2023-01-25
- Substance
- TERIFLUNOMIDE
- Active strength
- 7 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 | 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 |
|---|
| 62332-313-14 | TERIFLUNOMIDE | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 18 |
| 62332-313-14 | TERIFLUNOMIDE | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 18 |
| 62332-313-30 | TERIFLUNOMIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-313 | TERIFLUNOMIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] | 17 | Current NDC, 3 package rows | 20250406_8c1bc23b-a62b-4172-a603-8b97761514b4.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 |
|---|
| 62332-313-14 | 62332031314 | 2 BLISTER PACK in 1 CARTON (62332-313-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2023-01-25 | No | No | Current |
| 62332-313-30 | 62332031330 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-313-30) | | 2023-01-25 | No | No | Current |