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.NDC labeler code 62332
- 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.
About NDC 62332-314
- What is NDC 62332-314?
- 62332-314 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 3 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?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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 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 |