Enalaprilat Injection
NDC Package 43598-078-58

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. This formulation utilizes a injection delivery system. Marketed by Dr. Reddys Laboratories Inc, this product is identified by NDC 43598-078 and is authorized under FDA application ANDA075578.

Identification & Billing

NDC Package Code
43598-078-58
Package Description
10 VIAL in 1 CARTON / 1 mL in 1 VIAL (43598-078-11)
Product Code
43598-078
11-Digit Billing Format
43598007858
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Enalaprilat
Non-Proprietary Name
Enalaprilat
Substance Name
Enalaprilat
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ENALAPRILAT 1.25 mg/mL
Pharmacologic Class
Usage Information
Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, 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 enalaprilat injection does not have a similar risk (see WARNINGS). In considering use of enalaprilat, 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, Angioedema).

Regulatory & Marketing

Labeler Name
Dr. Reddys Laboratories Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA075578
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-06-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43598-078-58 identifies a specific commercial package of 10 vial in 1 carton / 1 ml in 1 vial (43598-078-11) of Enalaprilat, a human prescription drug labeled by Dr. Reddys Laboratories Inc. This injection is formulated for intravenous use and contains enalaprilat 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 Dr. Reddys Laboratories Inc on June 06, 2023. The current certification is valid through December 31, 2026.

How is this Dr. Reddys Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598007858. 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)
43598-078-58
11-Digit CMS (5-4-2)
43598-0078-58

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