Isosorbide Mononitrate
NDC Package 71610-321-05

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 inactivated by the FDA.

Isosorbide Mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-321 and is authorized under FDA application ANDA210918.

Identification & Billing

NDC Package Code
71610-321-05
Package Description
4200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
71610-321
11-Digit Billing Format
71610032105
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4200 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
  • RxCUI: 317110 - isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet
  • RxCUI: 317110 - 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet

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
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
ANDA210918
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-05-2018
Listing Expiration
12-31-2022
Exclude Flag
I
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 71610-321-05 identifies a specific commercial package of 4200 tablet, extended release in 1 bottle, plastic of Isosorbide Mononitrate, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 4200 billable units per package. 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 Aphena Pharma Solutions - Tennessee, Llc on November 05, 2018. The current certification is valid through December 31, 2022.

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 Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610032105. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4200 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)
71610-321-05
11-Digit CMS (5-4-2)
71610-0321-05

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