Hydralazine Hydrochloride
NDC Package 17478-834-01

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Hydralazine Hydrochloride is a . Marketed by Akorn, Inc., this product is identified by NDC 17478-834 and is authorized under FDA application ANDA040730.

Identification & Billing

NDC Package Code
17478-834-01
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
17478-834
11-Digit Billing Format
17478083401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Hydralazine Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Akorn, Inc.
FDA Application #
ANDA040730
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-21-2013
End Marketing Date
06-30-2018
Listing Expiration
06-30-2018
Exclude Flag
D
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 (17478-834). Click a package code to view its specific billing and regulatory data.

17478-834-15
25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

* 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 17478-834-01 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose of Hydralazine Hydrochloride, labeled by Akorn, Inc.. 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 Akorn, Inc. on February 21, 2013. The current certification is valid through June 30, 2018.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17478083401. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
17478-834-01
11-Digit CMS (5-4-2)
17478-0834-01

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