Rufinamide NDC 59651-617

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-617Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0617Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59651-617-08	59651061708	120 TABLET, FILM COATED in 1 BOTTLE (59651-617-08)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 — 400 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: Jun 16, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 59651-617_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

N459651061708 followed by a unit qualifier and the quantity

Package 59651-0617-08. 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 Jul 19, 2025.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217230

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217230
Product	Strength	Form · route	Labeler	Product NDC
Rufinamide	Rufinamide 200 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-616