Isosorbide Mononitrate Tablet, Extended Release
NDC Package 42799-960-01

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

Package Information

Isosorbide Mononitrate tablets is isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This formulation utilizes a tablet, extended release delivery system. Marketed by Edenbridge Pharmaceuticals Llc., this product is identified by NDC 42799-960 and is authorized under FDA application ANDA210822.

Identification & Billing

NDC Package Code
42799-960-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
42799-960
11-Digit Billing Format
42799096001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 311196 - isosorbide mononitrate 120 MG 24HR Extended Release Oral Tablet
  • RxCUI: 311196 - 24 HR isosorbide mononitrate 120 MG Extended Release Oral Tablet
  • RxCUI: 311196 - isosorbide mononitrate 120 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Isosorbide Mononitrate
Non-Proprietary Name
Isosorbide Mononitrate
Substance Name
Isosorbide Mononitrate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ISOSORBIDE MONONITRATE 120 mg/1
Pharmacologic Class
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
Edenbridge Pharmaceuticals Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210822
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-15-2018
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 42799-960-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Isosorbide Mononitrate, a human prescription drug labeled by Edenbridge Pharmaceuticals Llc.. This tablet, extended release is formulated for oral use and contains isosorbide mononitrate 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 Edenbridge Pharmaceuticals Llc. on November 15, 2018. The current certification is valid through December 31, 2026.

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 Edenbridge Pharmaceuticals Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42799096001. 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 (5-3-2)
42799-960-01
11-Digit CMS (5-4-2)
42799-0960-01

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