Teriflunomide
- Product NDC
- 69339-170
- 11-digit product format
- 693390170
- Labeler code
- 69339
- Product ID
- 69339-170_70bc9344-abbf-4aca-96c0-7f10cfe9aae4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriflunomide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Natco Pharma USA LLC
- Application
- ANDA209555
- Marketing category
- ANDA
- Marketing start
- 2023-06-17
- 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 |
|---|
| 69339-170-03 | Teriflunomide | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 69339-170-09 | Teriflunomide | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
| 69339-170-93 | Teriflunomide | 2 in 1 CARTON | TABLET | 2 | | 4 |
| 69339-170-93 | Teriflunomide | 30 in 1 BLISTER PACK | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69339-170 | TERIFLUNOMIDE TABLET [NATCO PHARMA USA LLC] | 4 | Current NDC, 4 package rows | 20240109_8219b4a2-fb9d-4387-ba33-96d28aad71dd.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 |
|---|
| 69339-170-03 | 69339017003 | 30 TABLET in 1 BOTTLE (69339-170-03) | 30 tablet | 2024-01-02 | No | No | Current |
| 69339-170-09 | 69339017009 | 90 TABLET in 1 BOTTLE (69339-170-09) | 90 tablet | 2024-01-02 | No | No | Current |
| 69339-170-93 | 69339017093 | 2 BLISTER PACK in 1 CARTON (69339-170-93) / 30 TABLET in 1 BLISTER PACK | 2 blister pack | 2023-06-17 | No | No | Current |