Bidil Tablet, Film Coated
NDC Package 24338-010-12

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

Bidil (hydralazine hydrochloride and isosorbide dinitrate) tablets is this medication contains 2 drugs (hydralazine and isosorbide dinitrate) and is used with other medications to treat heart failure. This formulation utilizes a tablet, film coated delivery system. Marketed by Azurity Pharmaceuticals, Inc., this product is identified by NDC 24338-010 and is authorized under FDA application NDA020727.

Identification & Billing

NDC Package Code
24338-010-12
Package Description
12 TABLET, FILM COATED in 1 BOTTLE
Product Code
24338-010
11-Digit Billing Format
24338001012
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
  • RxCUI: 905379 - BiDil 20 MG / 37.5 MG Oral Tablet
  • RxCUI: 905379 - hydralazine hydrochloride 37.5 MG / isosorbide dinitrate 20 MG Oral Tablet [Bidil]

Clinical Specifications

Proprietary Name
Bidil
Non-Proprietary Name
Hydralazine Hydrochloride And Isosorbide Dinitrate
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
This medication contains 2 drugs (hydralazine and isosorbide dinitrate) and is used with other medications to treat heart failure. Both drugs are known as vasodilators. They work by relaxing and widening blood vessels so blood can flow more easily to the heart.

Regulatory & Marketing

Labeler Name
Azurity Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020727
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-05-2012
Listing Expiration
12-31-2027
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 (24338-010). Click a package code to view its specific billing and regulatory data.

24338-010-09
90 TABLET, FILM COATED in 1 BOTTLE
24338-010-18
180 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 24338-010-12 identifies a specific commercial package of 12 tablet, film coated in 1 bottle of Bidil, a human prescription drug labeled by Azurity Pharmaceuticals, Inc.. 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 Azurity Pharmaceuticals, Inc. on December 05, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication contains 2 drugs (hydralazine and isosorbide dinitrate) and is used with other medications to treat heart failure. Both drugs are known as vasodilators. They work by relaxing and widening blood vessels so blood can flow more easily to the heart.

How is this Azurity Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24338001012. 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)
24338-010-12
11-Digit CMS (5-4-2)
24338-0010-12

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