Isosorbide Dinitrate, Diluted Powder
NDC Package 54864-106-34

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Isosorbide Dinitrate, Diluted powders is isosorbide dinitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This formulation utilizes a powder delivery system. Marketed by Dottikon Exclusive Synthesis Ag, this product is identified by NDC 54864-106.

Identification & Billing

NDC Package Code
54864-106-34
Package Description
50 kg in 1 DRUM
Product Code
54864-106
11-Digit Billing Format
54864010634

Clinical Specifications

Proprietary Name
Isosorbide Dinitrate, Diluted
Non-Proprietary Name
Isosorbide Dinitrate, Diluted
Substance Name
Isosorbide Dinitrate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ISOSORBIDE DINITRATE 100 kg/100kg
Usage Information
Isosorbide dinitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart. This medication will not relieve chest pain once it occurs. It is also not intended to be taken just before physical activities (such as exercise, sexual activity) to prevent chest pain. Other medications may be needed in these situations. Consult your doctor for more details.

Regulatory & Marketing

Labeler Name
Dottikon Exclusive Synthesis Ag
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-1983
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54864-106). Click a package code to view its specific billing and regulatory data.

54864-106-15
50 kg in 1 DRUM

* 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 54864-106-34 identifies a specific commercial package of 50 kg in 1 drum of Isosorbide Dinitrate, Diluted (UNFINISHED drug), a bulk ingredient labeled by Dottikon Exclusive Synthesis Ag. This powder is formulated for use and contains isosorbide dinitrate 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 Dottikon Exclusive Synthesis Ag on January 01, 1983. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Isosorbide dinitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart. This medication will not relieve chest pain once it occurs. It is also not intended to be taken just before physical activities (such as exercise, sexual activity) to prevent chest pain. Other medications may be needed in these situations. Consult your doctor for more details.

How is this Dottikon Exclusive Synthesis Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54864010634. 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)
54864-106-34
11-Digit CMS (5-4-2)
54864-0106-34

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