Entresto Tablet, Film Coated
NDC Package 71610-810-89

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

Entresto (sacubitril and valsartan) tablets is a medication used to treat certain types of heart failure. This formulation utilizes a tablet, film coated delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-810 and is authorized under FDA application NDA207620.

Identification & Billing

NDC Package Code
71610-810-89
Package Description
720 TABLET, FILM COATED in 1 BOTTLE
Product Code
71610-810
11-Digit Billing Format
71610081089
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
720 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Entresto
Non-Proprietary Name
Sacubitril And Valsartan
Substance Name
Sacubitril; Valsartan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product is used to treat certain types of heart failure. It may help you live longer and lower your chance of having to go to the hospital for heart failure. This product contains 2 medications: sacubitril and valsartan. Sacubitril belongs to a class of drugs called neprilysin inhibitors and valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). They work by relaxing blood vessels so that blood can flow more easily, which makes it easier for your heart to pump blood to your body.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA207620
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-07-2015
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 (71610-810). Click a package code to view its specific billing and regulatory data.

71610-810-32
780 TABLET, FILM COATED in 1 BOTTLE
71610-810-88
900 TABLET, FILM COATED 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 71610-810-89 identifies a specific commercial package of 720 tablet, film coated in 1 bottle of Entresto, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 720 billable units per package. This tablet, film coated is formulated for oral use and contains sacubitril; valsartan 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 Aphena Pharma Solutions - Tennessee, Llc on July 07, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to treat certain types of heart failure. It may help you live longer and lower your chance of having to go to the hospital for heart failure. This product contains 2 medications: sacubitril and valsartan. Sacubitril belongs to a class of drugs called neprilysin inhibitors and valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). They work by relaxing blood vessels so that blood can flow more easily, which makes it easier for your heart to pump blood to your body.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610081089. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 720 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)
71610-810-89
11-Digit CMS (5-4-2)
71610-0810-89

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