Rufinamide NDC 0054-0425

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0425Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0425Add 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
0054-0425-23	00054042523	120 TABLET, FILM COATED in 1 BOTTLE (0054-0425-23)Marketed from May 30, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204988
Marketing start: May 30, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 0054-0425_72348f03-413e-4d00-be89-00c719af669bSPL ID 72348f03-413e-4d00-be89-00c719af669bSPL set ID 56316809-6e73-4717-990b-fc84bf6bf433RxCUI 824295, 824301UNII WFW942PR79UPC 0300540425234, 0300540426231

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

N400054042523 followed by a unit qualifier and the quantity

Package 00054-0425-23. 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 May 31, 2021.

Indications (excerpt from the label)

Rufinamide is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide is 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 204988

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

FDA NDC Directory listings under ANDA 204988
Product	Strength	Form · route	Labeler	Product NDC
Rufinamide	Rufinamide 400 mg/1	Tablet, Film coatedOral	Hikma Pharmaceuticals USA Inc.	0054-0426