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NDC 00378-0628-93 Teriflunomide 14 mg/1 Details
Teriflunomide 14 mg/1
Teriflunomide is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is TERIFLUNOMIDE.
MedlinePlus Drug Summary
Teriflunomide is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including: clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Teriflunomide is in a class of medications called immunomodulatory agents. It is thought to work by decreasing inflammation and decreasing the action of immune cells that may cause nerve damage.
Related Packages: 00378-0628-93Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Teriflunomide
Product Information
| NDC | 00378-0628 |
|---|---|
| Product ID | 0378-0628_1824aae5-58af-43da-8231-435c8f118bc0 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Teriflunomide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Teriflunomide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 14 |
| Active Ingredient Units | mg/1 |
| Substance Name | TERIFLUNOMIDE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209702 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-0628-93 (00378062893)
| NDC Package Code | 0378-0628-93 |
|---|---|
| Billing NDC | 00378062893 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0628-93) |
| Marketing Start Date | 2023-03-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |