Benazepril Hydrochloride
NDC Package 16590-280-30

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.

Benazepril Hydrochloride is iNDICATIONS AND USAGE Benazepril hydrochloride is indicated for the treatment of hypertension. Marketed by Stat Rx Usa, this product is identified by NDC 16590-280 and is authorized under FDA application ANDA076820.

Identification & Billing

NDC Package Code
16590-280-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
16590-280
11-Digit Billing Format
16590028030
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Benazepril Hydrochloride
Dosage Form
-
Usage Information
INDICATIONS AND USAGE Benazepril hydrochloride is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.In using Benazepril hydrochloride, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Benazepril hydrochloride does not have a similar risk (see WARNINGS).Black patients receiving ACE-inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks

Regulatory & Marketing

Labeler Name
Stat Rx Usa
FDA Application #
ANDA076820
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-27-2009
Listing Expiration
12-31-2017
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 16590-280-30 identifies a specific commercial package of 30 tablet in 1 bottle of Benazepril Hydrochloride, labeled by Stat Rx Usa. 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 Stat Rx Usa on October 27, 2009. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590028030. 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)
16590-280-30
11-Digit CMS (5-4-2)
16590-0280-30

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