Nexterone Injection, Solution
NDC Package 43066-360-20

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

Package Information

Nexterone (amiodarone hydrochloride) injection is nEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 43066-360 and is authorized under FDA application NDA022325.

Identification & Billing

NDC Package Code
43066-360-20
Package Description
200 mL in 1 BAG
Product Code
43066-360
11-Digit Billing Format
43066036020
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
200 ML

Clinical Specifications

Proprietary Name
Nexterone
Non-Proprietary Name
Amiodarone Hydrochloride
Substance Name
Amiodarone Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
AMIODARONE HYDROCHLORIDE 1.8 mg/mL
Pharmacologic Class
Usage Information
NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)].Use NEXTERONE for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE may be safely administered for longer periods if necessary.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA022325
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-16-2010
Listing Expiration
12-31-2027
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 43066-360-20 identifies a specific commercial package of 200 ml in 1 bag of Nexterone, a human prescription drug labeled by Baxter Healthcare Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 200 billable units per package. This injection, solution is formulated for intravenous use and contains amiodarone hydrochloride 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 Baxter Healthcare Corporation on November 16, 2010. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43066036020. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 200 total billable units per package. 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)
43066-360-20
11-Digit CMS (5-4-2)
43066-0360-20

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