Enalapril Maleate And Hydrochlorothiazide Tablet
NDC Package 51672-4045-3

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

Enalapril Maleate And Hydrochlorothiazide tablets is enalapril maleate and hydrochlorothiazide is indicated for the treatment of hypertension.This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION).In using enalapril maleate and hydrochlorothiazide, 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 does not have a similar risk (see WARNINGS).In considering use of enalapril maleate and hydrochlorothiazide, 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). This formulation utilizes a tablet delivery system. Marketed by Taro Pharmaceuticals U.s.a., Inc., this product is identified by NDC 51672-4045 and is authorized under FDA application ANDA075788.

Identification & Billing

NDC Package Code
51672-4045-3
Package Description
1000 TABLET in 1 BOTTLE
Product Code
51672-4045
11-Digit Billing Format
51672404503
RxNorm Crosswalk
  • RxCUI: 858824 - enalapril maleate 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 858824 - enalapril maleate 5 MG / hydrochlorothiazide 12.5 MG Oral Tablet
  • RxCUI: 858824 - enalapril maleate 5 MG / HCTZ 12.5 MG Oral Tablet
  • RxCUI: 858828 - enalapril maleate 10 MG / hydroCHLOROthiazide 25 MG Oral Tablet
  • RxCUI: 858828 - enalapril maleate 10 MG / hydrochlorothiazide 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Enalapril Maleate And Hydrochlorothiazide
Non-Proprietary Name
Enalapril Maleate And Hydrochlorothiazide
Substance Name
Enalapril Maleate; Hydrochlorothiazide
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)
Pharmacologic Class
Usage Information
Enalapril maleate and hydrochlorothiazide is indicated for the treatment of hypertension.This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION).In using enalapril maleate and hydrochlorothiazide, 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 does not have a similar risk (see WARNINGS).In considering use of enalapril maleate and hydrochlorothiazide, 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
Taro Pharmaceuticals U.s.a., Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075788
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-18-2001
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 (51672-4045). Click a package code to view its specific billing and regulatory data.

51672-4045-1
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 51672-4045-3 identifies a specific commercial package of 1000 tablet in 1 bottle of Enalapril Maleate And Hydrochlorothiazide, a human prescription drug labeled by Taro Pharmaceuticals U.s.a., Inc.. This tablet is formulated for oral use and contains enalapril maleate; hydrochlorothiazide 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 Taro Pharmaceuticals U.s.a., Inc. on September 18, 2001. The current certification is valid through December 31, 2026.

How is this Taro Pharmaceuticals U.s.a., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672404503. 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 (5-4-1)
51672-4045-3
11-Digit CMS (5-4-2)
51672-4045-03

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