Hydralazine Hydrochloride Tablet
NDC Package 76282-310-10

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

Hydralazine Hydrochloride tablets is essential hypertension, alone or as an adjunct. This formulation utilizes a tablet delivery system. Marketed by Exelan Pharmaceuticals Inc., this product is identified by NDC 76282-310 and is authorized under FDA application ANDA090255.

Identification & Billing

NDC Package Code
76282-310-10
Package Description
1000 TABLET in 1 BOTTLE
Product Code
76282-310
11-Digit Billing Format
76282031010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydralazine Hydrochloride
Non-Proprietary Name
Hydralazine Hydrochloride
Substance Name
Hydralazine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDRALAZINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Essential hypertension, alone or as an adjunct.

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090255
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-20-2016
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 (76282-310). Click a package code to view its specific billing and regulatory data.

76282-310-01
100 TABLET 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 76282-310-10 identifies a specific commercial package of 1000 tablet in 1 bottle of Hydralazine Hydrochloride, a human prescription drug labeled by Exelan Pharmaceuticals Inc.. This tablet is formulated for oral use and contains hydralazine hydrochloride 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 Exelan Pharmaceuticals Inc. on May 20, 2016. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282031010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 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)
76282-310-10
11-Digit CMS (5-4-2)
76282-0310-10

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