Enalapril Maleate
NDC Package 72189-151-90

11-digit billing NDC: 72189015190
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.

Enalapril Maleate is hypertensionEnalapril maleate is indicated for the treatment of hypertension. Marketed by Direct Rx, this product is identified by NDC 72189-151 and is authorized under FDA application ANDA075657.

Identification & Billing

NDC Package Code
72189-151-90
Package Description
90 TABLET in 1 BOTTLE
Product Code
72189-151
11-Digit Billing Format
72189015190
RxNorm Crosswalk
RxCUI: 858817 - enalapril maleate 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Enalapril Maleate
Dosage Form
-
Usage Information
HypertensionEnalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.Heart FailureEnalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, HEART FAILURE, MORTALITY TRIALS for details and limitations of survival trials).Asymptomatic Left Ventricular DysfunctionIn clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, HEART FAILURE, MORTALITY TRIALS for details and limitations of survival trials).In using enalapril maleate 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, and that available data are insufficient to show that enalapril maleate does not have a similar risk (see WARNINGS, NEUTROPENIA/AGRANULOCYTOSIS).In considering use of enalapril maleate, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, HEAD AND NECK ANGIOEDEMA).

Regulatory & Marketing

Labeler Name
Direct Rx
FDA Application #
ANDA075657
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-12-2020
Listing Expiration
12-31-2024
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 72189-151-90 identifies a specific commercial package of 90 tablet in 1 bottle of Enalapril Maleate, labeled by Direct Rx. 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 Direct Rx on November 12, 2020. The current certification is valid through December 31, 2024.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189015190. 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)
72189-151-90
11-Digit CMS (5-4-2)
72189-0151-90

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