Rufinamide NDC 69452-223

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-223Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0223Add 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
69452-223-84	69452022384	1 BOTTLE in 1 CARTON (69452-223-84) / 460 mL in 1 BOTTLEMarketed from Nov 6, 2020

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 — 40 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: Bionpharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211388
Marketing start: Dec 19, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 69452-223_3d338656-9665-cc13-e063-6294a90ab433SPL ID 3d338656-9665-cc13-e063-6294a90ab433SPL set ID e2ba061a-49f0-4330-b0f0-00f2c3725625RxCUI 1092357UNII WFW942PR79UPC 0369452223840

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

N469452022384 followed by a unit qualifier and the quantity

Package 69452-0223-84. 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 Aug 26, 2025.

Indications (excerpt from the label)

Rufinamide oral suspension 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)