Isosorbide Mononitrate
NDC Package 0904-6451-61

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Isosorbide Mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-6451 and is authorized under FDA application ANDA200495.

Identification & Billing

NDC Package Code
0904-6451-61
Package Description
100 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0904-6451
11-Digit Billing Format
00904645161
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Isosorbide Mononitrate
Dosage Form
-
Usage Information
Isosorbide mononitrate 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. Also, it is not intended to be taken just before physical activities (such as exercise or sexual intercourse) to prevent chest pain. Other medications may be prescribed by your doctor for these conditions. Consult your doctor for more details.

Regulatory & Marketing

Labeler Name
Major Pharmaceuticals
FDA Application #
ANDA200495
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-05-2015
End Marketing Date
04-19-2023
Listing Expiration
04-19-2023
Exclude Flag
D
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 0904-6451-61 identifies a specific commercial package of 100 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack of Isosorbide Mononitrate, labeled by Major Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Major Pharmaceuticals on January 05, 2015. The current certification is valid through April 19, 2023.

What are the primary indications for this medication?

Isosorbide mononitrate 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. Also, it is not intended to be taken just before physical activities (such as exercise or sexual intercourse) to prevent chest pain. Other medications may be prescribed by your doctor for these conditions. Consult your doctor for more details.

How is this Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904645161. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
0904-6451-61
11-Digit CMS (5-4-2)
00904-6451-61

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