Teriflunomide
- Product NDC
- 70377-018
- 11-digit product format
- 703770018
- Labeler code
- 70377
- Product ID
- 70377-018_239c5b66-c188-defa-3062-fe6dfa60e101
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Biocon Pharma Inc.
- Application
- ANDA209639
- Marketing category
- ANDA
- Marketing start
- 2023-03-13
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Teriflunomide
- Listing expiration
- 2026-12-31
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 |
|---|
| 70377-018-11 | Teriflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 70377-018-91 | Teriflunomide | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 9 |
| 70377-018-91 | Teriflunomide | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70377-018 | TERIFLUNOMIDE (TERIFLUNOMIDE) TABLET, FILM COATED [BIOCON PHARMA INC.] | 8 | Current NDC, 3 package rows | 20230331_37f04f8b-001e-66ff-4574-cc34cebce61c.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 |
|---|
| 70377-018-11 | 70377001811 | 30 TABLET, FILM COATED in 1 BOTTLE (70377-018-11) | | 2023-03-13 | No | No | Historical |
| 70377-018-91 | 70377001891 | 2 BLISTER PACK in 1 CARTON (70377-018-91) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2023-03-13 | No | No | Historical |