Nitroglycerin Injection, Solution
NDC Package 0404-9928-10

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

Package Information

Nitroglycerin injection is a medication used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). This formulation utilizes a injection, solution delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9928 and is authorized under FDA application ANDA072034.

Identification & Billing

NDC Package Code
0404-9928-10
Package Description
1 VIAL in 1 BAG / 10 mL in 1 VIAL
Product Code
0404-9928
11-Digit Billing Format
00404992810
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nitroglycerin
Non-Proprietary Name
Nitroglycerin
Substance Name
Nitroglycerin
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)
NITROGLYCERIN 5 mg/mL
Pharmacologic Class
Usage Information
This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart.

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA072034
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-13-2022
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.

* 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 0404-9928-10 identifies a specific commercial package of 1 vial in 1 bag / 10 ml in 1 vial of Nitroglycerin, a human prescription drug labeled by Henry Schein, Inc.. This injection, solution is formulated for intravenous use and contains nitroglycerin 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 13, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404992810. 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)
0404-9928-10
11-Digit CMS (5-4-2)
00404-9928-10

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