Prescription drug · ANDA
Rufinamide NDC 59651-616
Rufinamide 200 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-616-08 | 59651061608 | 120 TABLET, FILM COATED in 1 BOTTLE (59651-616-08)Marketed from Jun 16, 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)
- Rufinamide
- Generic name (nonproprietary)
- rufinamide
- Active ingredients
- Rufinamide — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217230
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-616_96d61d77-4de0-4c57-997d-014010177a86SPL ID 96d61d77-4de0-4c57-997d-014010177a86SPL set ID d9ffc833-d902-41cb-8e8e-6bbba8e65b9eRxCUI 824295, 824301UNII WFW942PR79UPC 0359651616086
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
N459651061608followed by a unit qualifier and the quantityPackage 59651-0616-08. 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 .
Indications (excerpt from the label)
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217230
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 |
|---|---|---|---|---|
| Rufinamide | Rufinamide 400 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-617 |