Amiodarone Hydrochloride
NDC Package 14335-430-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amiodarone Hydrochloride is amiodarone injection 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. Marketed by Hainan Poly Pharm. Co., Ltd., this product is identified by NDC 14335-430 and is authorized under FDA application ANDA218253.

Identification & Billing

NDC Package Code
14335-430-10
Package Description
3 mL in 1 VIAL, GLASS
Product Code
14335-430
11-Digit Billing Format
14335043010
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amiodarone Hydrochloride
Dosage Form
-
Usage Information
Amiodarone injection 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. Amiodarone 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 amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.

Regulatory & Marketing

Labeler Name
Hainan Poly Pharm. Co., Ltd.
FDA Application #
ANDA218253
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-06-2023
Listing Expiration
12-31-2025
Exclude Flag
I
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 14335-430-10 identifies a specific commercial package of 3 ml in 1 vial, glass of Amiodarone Hydrochloride, labeled by Hainan Poly Pharm. Co., Ltd.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Hainan Poly Pharm. Co., Ltd. on February 06, 2023. The current certification is valid through December 31, 2025.

How is this Hainan Poly Pharm. Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14335043010. 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)
14335-430-10
11-Digit CMS (5-4-2)
14335-0430-10

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