Prescription drug · ANDA
Teriflunomide NDC 69339-170
Teriflunomide 14 mg/1 · Tablet · Oral · Natco Pharma USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69339-170-03 | 69339017003 | 30 TABLET in 1 BOTTLE (69339-170-03)Marketed from Jan 2, 2024 | |
| 69339-170-09 | 69339017009 | 90 TABLET in 1 BOTTLE (69339-170-09)Marketed from Jan 2, 2024 | |
| 69339-170-93 | 69339017093 | 2 BLISTER PACK in 1 CARTON (69339-170-93) / 30 TABLET in 1 BLISTER PACKMarketed from Jun 17, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Teriflunomide
- Generic name (nonproprietary)
- teriflunomide
- Active ingredients
- Teriflunomide — 14 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Natco Pharma USA LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209555
- Marketing start
- Listing expires
- Other FDA classes
- Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69339-170_70bc9344-abbf-4aca-96c0-7f10cfe9aae4SPL ID 70bc9344-abbf-4aca-96c0-7f10cfe9aae4SPL set ID 8219b4a2-fb9d-4387-ba33-96d28aad71ddRxCUI 1310525, 1310533UNII 1C058IKG3BUPC 0369339170090, 0369339169032, 0369339169094
- Pharmacologic class
- Pyrimidine Synthesis Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469339017003followed by a unit qualifier and the quantityPackage 69339-0170-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Teriflunomide tablets are a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209555
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Teriflunomide | Teriflunomide 7 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-169 |