Teriflunomide
- Product NDC
- 0115-1565
- 11-digit product format
- 001151565
- Labeler code
- 0115
- Product ID
- 0115-1565_ed5b2e8a-3ef9-44c2-ba77-b75abbd811e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA209677
- Marketing category
- ANDA
- Marketing start
- 2020-06-17
- Marketing end
- 0000-00-00
- Substance
- TERIFLUNOMIDE
- Active strength
- 14 mg/1
- Pharmacologic classes
- Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1565 | TERIFLUNOMIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 1 | Legacy NDC | 20200619_57a0226d-74a3-4753-8683-ddc86dade0ae.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-1565-44 | 00115156544 | 28 TABLET, FILM COATED in 1 CARTON (0115-1565-44) | 2020-06-17 | 0000-00-00 | No | No | Current |