Brevibloc Injection
NDC Package 0404-9825-10

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

Package Information

Brevibloc (esmolol hydrochloride) injection is bREVIBLOC (Esmolol Hydrochloride) is contraindicated in patients with:Severe sinus bradycardia:  May precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions (5.2)].Heart block greater than first degree:  Second- or third-degree atrioventricular block may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions (5.2)].Sick sinus syndrome:  May precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions (5.2)].Decompensated heart failure:  May worsen heart failure.Cardiogenic shock:  May precipitate further cardiovascular collapse and cause cardiac arrest.IV administration of cardiodepressant calcium-channel antagonists (e.g., verapamil) and BREVIBLOC in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving BREVIBLOC and intravenous verapamil.Pulmonary hypertension:  May precipitate cardiorespiratory compromise.Hypersensitivity reactions, including anaphylaxis to esmolol or any of the inactive ingredients of the product (cross-sensitivity between beta blockers is possible). This formulation utilizes a injection delivery system. Marketed by Henry Schein, Inc, this product is identified by NDC 0404-9825 and is authorized under FDA application NDA019386.

Identification & Billing

NDC Package Code
0404-9825-10
Package Description
1 VIAL, SINGLE-DOSE in 1 BAG / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code
0404-9825
11-Digit Billing Format
00404982510
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Brevibloc
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
BREVIBLOC (Esmolol Hydrochloride) is contraindicated in patients with:Severe sinus bradycardia:  May precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions (5.2)].Heart block greater than first degree:  Second- or third-degree atrioventricular block may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions (5.2)].Sick sinus syndrome:  May precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions (5.2)].Decompensated heart failure:  May worsen heart failure.Cardiogenic shock:  May precipitate further cardiovascular collapse and cause cardiac arrest.IV administration of cardiodepressant calcium-channel antagonists (e.g., verapamil) and BREVIBLOC in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving BREVIBLOC and intravenous verapamil.Pulmonary hypertension:  May precipitate cardiorespiratory compromise.Hypersensitivity reactions, including anaphylaxis to esmolol or any of the inactive ingredients of the product (cross-sensitivity between beta blockers is possible).

Regulatory & Marketing

Labeler Name
Henry Schein, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA019386
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-09-2022
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0404-9825-10 identifies a specific commercial package of 1 vial, single-dose in 1 bag / 10 ml in 1 vial, single-dose of Brevibloc, a human prescription drug labeled by Henry Schein, Inc. 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 Henry Schein, Inc on January 09, 2022. 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: 00404982510. 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)
0404-9825-10
11-Digit CMS (5-4-2)
00404-9825-10

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