Prescription drug · ANDA
Teriflunomide NDC 62332-314
Teriflunomide 14 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-314-14 | 62332031414 | 2 BLISTER PACK in 1 CARTON (62332-314-14) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 25, 2023 | |
| 62332-314-30 | 62332031430 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-314-30)Marketed from Jan 25, 2023 | |
| 62332-314-91 | 62332031491 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-314-91)Marketed from Jan 25, 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, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209572
- Marketing start
- Listing expires
- Other FDA classes
- Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
- Identifiers
- Product ID 62332-314_95e1ed70-9c5b-4bad-a26e-b33cd3f9b7eeSPL ID 95e1ed70-9c5b-4bad-a26e-b33cd3f9b7eeSPL set ID 8c1bc23b-a62b-4172-a603-8b97761514b4RxCUI 1310525, 1310533UNII 1C058IKG3BUPC 0362332313303, 0362332314300
- 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
N462332031414followed by a unit qualifier and the quantityPackage 62332-0314-14. 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 tablet 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 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209572
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 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-313 |
| Teriflunomide | Teriflunomide 14 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-314 |
| Teriflunomide | Teriflunomide 7 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-313 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.