Esmolol Hydrochloride Injection
NDC Package 68083-211-25

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

Package Information

Esmolol Hydrochloride injection is available in a ready-to-use vial. This formulation utilizes a injection delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-211 and is authorized under FDA application ANDA208538.

Identification & Billing

NDC Package Code
68083-211-25
Package Description
25 VIAL in 1 CARTON / 10 mL in 1 VIAL (68083-211-01)
Product Code
68083-211
11-Digit Billing Format
68083021125
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Esmolol Hydrochloride
Non-Proprietary Name
Esmolol Hydrochloride
Substance Name
Esmolol Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ESMOLOL HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
Usage Information
Esmolol hydrochloride injection is available in a ready-to-use vial. Esmolol hydrochloride injection is not compatible with Sodium Bicarbonate (5%) solution (limited stability) or furosemide (precipitation). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Ready-to-Use VialThe Ready-to-use Vial may be used to administer a loading dosage by hand-held syringe while the maintenance infusion is being prepared [see How Supplied/Storage and Handling (16.2)]. Compatibility with Commonly Used Intravenous FluidsEsmolol hydrochloride injection was tested for compatibility with ten commonly used intravenous fluids at a final concentration of 10 mg Esmolol Hydrochloride per mL. Esmolol hydrochloride injection was found to be compatible with the following solutions and was stable for at least 24 hours at controlled room temperature or under refrigeration: Dextrose (5%) Injection, USPDextrose (5%) in Lactated Ringer's Injection Dextrose (5%) in Ringer's InjectionDextrose (5%) and Sodium Chloride (0.45%) Injection, USPDextrose (5%) and Sodium Chloride (0.9%) Injection, USPLactated Ringer's Injection, USPPotassium Chloride (40 mEq/liter) in Dextrose (5%) Injection, USPSodium Chloride (0.45%) Injection, USPSodium Chloride (0.9%) Injection, USP

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA208538
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-19-2019
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 68083-211-25 identifies a specific commercial package of 25 vial in 1 carton / 10 ml in 1 vial (68083-211-01) of Esmolol Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. This injection is formulated for intravenous use and contains esmolol 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 August 19, 2019. 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: 68083021125. 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)
68083-211-25
11-Digit CMS (5-4-2)
68083-0211-25

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