Enalapril Maleate Tablet
NDC Package 68682-710-30

11-digit billing NDC: 68682071030 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Enalapril Maleate tablets is hypertensionEnalapril Maleate Tablets are indicated for the treatment of hypertension.Enalapril Maleate Tablets are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. This formulation utilizes a tablet delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-710 and is authorized under FDA application NDA018998.

Identification & Billing

NDC Package Code
68682-710-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
68682-710
11-Digit Billing Format
68682071030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Enalapril Maleate
Non-Proprietary Name
Enalapril Maleate
Substance Name
Enalapril Maleate
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)
ENALAPRIL MALEATE 2.5 mg/1
Pharmacologic Class
Usage Information
HypertensionEnalapril Maleate Tablets are indicated for the treatment of hypertension.Enalapril Maleate Tablets are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of Enalapril Maleate Tablets and thiazides are approximately additive.Heart FailureEnalapril Maleate Tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients Enalapril Maleate Tablets improve 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 Tablets decrease 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 Tablets 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 Tablets do not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis).In considering use of Enalapril Maleate Tablets, 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
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA018998
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-26-1988
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 (68682-710). Click a package code to view its specific billing and regulatory data.

68682-710-01
100 TABLET in 1 BOTTLE
68682-710-10
1000 TABLET in 1 BOTTLE
68682-710-90
90 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 68682-710-30 identifies a specific commercial package of 30 tablet in 1 bottle of Enalapril Maleate, a human prescription drug labeled by Oceanside Pharmaceuticals. This tablet is formulated for oral use and contains enalapril maleate 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 Oceanside Pharmaceuticals on July 26, 1988. The current certification is valid through December 31, 2027.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682071030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
68682-710-30
11-Digit CMS (5-4-2)
68682-0710-30

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