teriflunomide
- Product NDC
- 68462-312
- 11-digit product format
- 684620312
- Labeler code
- 68462
- Product ID
- 68462-312_547ff1b7-72fc-4820-b337-d8ee0202fefe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA209663
- Marketing category
- ANDA
- Marketing start
- 2020-05-01
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-312-84 | 68462031284 | 2 BLISTER PACK in 1 CARTON (68462-312-84) > 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2020-05-01 | 0000-00-00 | No | No | Current |
| 68462-312-85 | 68462031285 | 1 BLISTER PACK in 1 CARTON (68462-312-85) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2020-05-01 | 0000-00-00 | No | No | Current |