Prescription drug · ANDA
Teriflunomide NDC 70710-1114
Teriflunomide 7 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1114-3 | 70710111403 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1114-3)Marketed from Feb 14, 2023 | |
| 70710-1114-8 | 70710111408 | 2 CARTON in 1 CARTON (70710-1114-8) / 1 BLISTER PACK in 1 CARTON (70710-1114-7) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 14, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 7 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209668
- Marketing start
- Listing expires
- Other FDA classes
- Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
- Identifiers
- Product ID 70710-1114_52364a7a-fc8b-4d35-b24c-57f9cc367449SPL ID 52364a7a-fc8b-4d35-b24c-57f9cc367449SPL set ID cbf32b27-e63a-4544-9c1f-6564e82200e5RxCUI 1310525, 1310533UNII 1C058IKG3B
- 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
N470710111403followed by a unit qualifier and the quantityPackage 70710-1114-03. 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 is 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 ) Teriflunomide is 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.
Excerpt only. Read the full label for complete information.
About NDC 70710-1114
- What is NDC 70710-1114?
- 70710-1114 is the product NDC for Teriflunomide, Teriflunomide 7 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Teriflunomide.
- What is the active ingredient?
- Teriflunomide.
- Who is the labeler?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Teriflunomide?
- 31 other product NDCs are listed under this name. See all Teriflunomide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Teriflunomide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Teriflunomide | Teriflunomide 14 mg/141 | Tablet, Film coatedOral | CONCORD BIOTECH LIMITED | 68254-5010 | 68254-5010-01 |
| Teriflunomide | Teriflunomide 7 mg/1 | Tablet, Film coatedOral | CONCORD BIOTECH LIMITED | 68254-5013 | 68254-5013-01 |
| Teriflunomide | Teriflunomide 7 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-169 | 69339-0169-0369339-0169-0969339-0169-93 |
| Teriflunomide | Teriflunomide 14 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-170 | 69339-0170-0369339-0170-0969339-0170-93 |
| Teriflunomide | Teriflunomide 7 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-830 | 42291-0830-30 |
| Teriflunomide | Teriflunomide 14 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-831 | 42291-0831-30 |
| Teriflunomide | Teriflunomide 14 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3156 | 00480-3156-56 |
| Teriflunomide | Teriflunomide 7 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3157 | 00480-3157-56 |
| Teriflunomide | Teriflunomide 7 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-399 | 16729-0399-10 |
| Teriflunomide | Teriflunomide 14 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-400 | 16729-0400-10 |
Other NDCs under ANDA 209668
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 14 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1115 |
| Teriflunomide | Teriflunomide 7 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1010 |
| Teriflunomide | Teriflunomide 14 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1011 |