Esmolol Hydrochloride Injection, Solution
NDC Package 0404-9785-10

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 1.1 Supraventricular Tachycardia or Noncompensatory Sinus TachycardiaEsmolol hydrochloride injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. This formulation utilizes a injection, solution delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9785 and is authorized under FDA application ANDA076474.

Identification & Billing

NDC Package Code
0404-9785-10
Package Description
1 VIAL in 1 BAG / 10 mL in 1 VIAL
Product Code
0404-9785
11-Digit Billing Format
00404978510
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Esmolol Hydrochloride
Non-Proprietary Name
Esmolol Hydrochloride
Substance Name
Esmolol 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)
ESMOLOL HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
Usage Information
1.1 Supraventricular Tachycardia or Noncompensatory Sinus TachycardiaEsmolol hydrochloride injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. Esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride injection is intended for short-term use.1.2 Intraoperative and Postoperative Tachycardia and/or HypertensionEsmolol hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated.Use of esmolol hydrochloride injection to prevent such events is not recommended.

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076474
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-10-2025
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 0404-9785-10 identifies a specific commercial package of 1 vial in 1 bag / 10 ml in 1 vial of Esmolol Hydrochloride, a human prescription drug labeled by Henry Schein, Inc.. This injection, solution 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 Henry Schein, Inc. on June 10, 2025. The current certification is valid through December 31, 2026.

How is this Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404978510. 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 (4-4-2)
0404-9785-10
11-Digit CMS (5-4-2)
00404-9785-10

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