Teriflunomide
- Product NDC
- 69238-1304
- 11-digit product format
- 692381304
- Labeler code
- 69238
- Product ID
- 69238-1304_3cdb678e-3c0f-4331-a8d7-288741384e32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA209613
- Marketing category
- ANDA
- Marketing start
- 2018-10-01
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1304 | TERIFLUNOMIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 10 | Legacy NDC | 20250221_1f054d91-aede-4c1a-9aba-04f40d11e4d1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69238-1304-2 | 69238130402 | 2 BLISTER PACK in 1 CARTON (69238-1304-2) > 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2018-10-01 | 0000-00-00 | No | No | Current |
| 69238-1304-6 | 69238130406 | 28 TABLET, FILM COATED in 1 BOTTLE (69238-1304-6) | | 2018-10-01 | 0000-00-00 | No | No | Current |