Sacubitril And Valsartan Tablet, Film Coated
NDC Package 85468-075-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Sacubitril And Valsartan tablets is a drug for further processing. This formulation utilizes a tablet, film coated delivery system. Marketed by Synthon Chile Limitada, this product is identified by NDC 85468-075.

Identification & Billing

NDC Package Code
85468-075-00
Package Description
31500 TABLET, FILM COATED in 1 DRUM
Product Code
85468-075
11-Digit Billing Format
85468007500

Clinical Specifications

Proprietary Name
Sacubitril And Valsartan
Non-Proprietary Name
Sacubitril And Valsartan
Substance Name
Sacubitril Sodium; Valsartan Disodium
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.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Synthon Chile Limitada
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
03-18-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 85468-075-00 identifies a specific commercial package of 31500 tablet, film coated in 1 drum of Sacubitril And Valsartan (UNFINISHED drug), drug for further processing labeled by Synthon Chile Limitada. This tablet, film coated is formulated for use and contains sacubitril sodium; valsartan disodium 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 Synthon Chile Limitada on March 18, 2026. The current certification is valid through December 31, 2027.

How is this Synthon Chile Limitada product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85468007500. 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)
85468-075-00
11-Digit CMS (5-4-2)
85468-0075-00

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