Amiodarone Hydrochloride Injection, Solution
NDC Package 68083-112-01

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

Package Information

Amiodarone Hydrochloride injection 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. This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-112 and is authorized under FDA application ANDA077161.

Identification & Billing

NDC Package Code
68083-112-01
Package Description
10 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE
Product Code
68083-112
11-Digit Billing Format
68083011201
RxNorm Crosswalk
  • RxCUI: 834357 - amiodarone HCl 150 MG in 3 ML Prefilled Syringe
  • RxCUI: 834357 - 3 ML amiodarone hydrochloride 50 MG/ML Prefilled Syringe
  • RxCUI: 834357 - amiodarone hydrochloride 150 MG per 3 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Amiodarone Hydrochloride
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 50 mg/mL
Pharmacologic Class
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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA077161
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2013
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 68083-112-01 identifies a specific commercial package of 10 syringe in 1 carton / 3 ml in 1 syringe of Amiodarone Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. 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 Gland Pharma Limited on July 15, 2013. The current certification is valid through December 31, 2026.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083011201. 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)
68083-112-01
11-Digit CMS (5-4-2)
68083-0112-01

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