Isosorbide Dinitrate And Hydralazine Hydrochloride Tablet, Film Coated
NDC Package 73141-012-18

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

Isosorbide Dinitrate And Hydralazine Hydrochloride tablets are contraindicated in patients who are allergic to organic nitrates.Do not use isosorbide dinitrate and hydralazine hydrochloride tablets in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. This formulation utilizes a tablet, film coated delivery system. Marketed by A2a Integrated Pharmaceuticals, this product is identified by NDC 73141-012 and is authorized under FDA application ANDA215988.

Identification & Billing

NDC Package Code
73141-012-18
Package Description
180 TABLET, FILM COATED in 1 BOTTLE
Product Code
73141-012
11-Digit Billing Format
73141001218
RxNorm Crosswalk
  • RxCUI: 905377 - isosorbide dinitrate 20 MG / hydrALAZINE HCl 37.5 MG Oral Tablet
  • RxCUI: 905377 - hydralazine hydrochloride 37.5 MG / isosorbide dinitrate 20 MG Oral Tablet
  • RxCUI: 905377 - Hydralazine Hydrochloride 37.5 MG / ISDN 20 MG Oral Tablet

Clinical Specifications

Proprietary Name
Isosorbide Dinitrate And Hydralazine Hydrochloride
Non-Proprietary Name
Isosorbide Dinitrate And Hydralazine Hydrochloride
Substance Name
Hydralazine Hydrochloride; Isosorbide Dinitrate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Isosorbide dinitrate and hydralazine hydrochloride tablets are contraindicated in patients who are allergic to organic nitrates.Do not use isosorbide dinitrate and hydralazine hydrochloride tablets in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1)]. Do not use isosorbide dinitrate and hydralazine hydrochloride tablets in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension.

Regulatory & Marketing

Labeler Name
A2a Integrated Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA215988
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-22-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (73141-012). Click a package code to view its specific billing and regulatory data.

73141-012-03
90 TABLET, FILM COATED in 1 BOTTLE

* 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 73141-012-18 identifies a specific commercial package of 180 tablet, film coated in 1 bottle of Isosorbide Dinitrate And Hydralazine Hydrochloride, a human prescription drug labeled by A2a Integrated Pharmaceuticals. This tablet, film coated is formulated for oral use and contains hydralazine hydrochloride; 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 A2a Integrated Pharmaceuticals on April 22, 2024. The current certification is valid through December 31, 2026.

How is this A2a Integrated Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73141001218. 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)
73141-012-18
11-Digit CMS (5-4-2)
73141-0012-18

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