Rufinamide Suspension
NDC Package 72603-261-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Rufinamide suspension is rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS). This formulation utilizes a suspension delivery system. Marketed by Northstar Rxllc, this product is identified by NDC 72603-261 and is authorized under FDA application ANDA216841.

Identification & Billing

NDC Package Code
72603-261-01
Package Description
1 BOTTLE in 1 CARTON / 460 mL in 1 BOTTLE
Product Code
72603-261
11-Digit Billing Format
72603026101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rufinamide
Non-Proprietary Name
Rufinamide
Substance Name
Rufinamide
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RUFINAMIDE 40 mg/mL
Usage Information
Rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS). This medication is an anticonvulsant. Rufinamide is thought to work by acting on the sodium channels in the brain that carry excessive electrical charges that may cause seizures.

Regulatory & Marketing

Labeler Name
Northstar Rxllc
Product Type
Human Prescription Drug
FDA Application #
ANDA216841
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72603-261-01 identifies a specific commercial package of 1 bottle in 1 carton / 460 ml in 1 bottle of Rufinamide, a human prescription drug labeled by Northstar Rxllc. This suspension is formulated for oral use and contains rufinamide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Northstar Rxllc on August 01, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS). This medication is an anticonvulsant. Rufinamide is thought to work by acting on the sodium channels in the brain that carry excessive electrical charges that may cause seizures.

How is this Northstar Rxllc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72603026101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
72603-261-01
11-Digit CMS (5-4-2)
72603-0261-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.