Sacubitril And Valsartan Tablet, Film Coated
NDC Package 67046-1624-3

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

Package Information

Sacubitril And Valsartan tablets are contraindicated:in patients with hypersensitivity to any componentin patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions (5.2)]with concomitant use of ACE inhibitors. This formulation utilizes a tablet, film coated delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-1624 and is authorized under FDA application ANDA213682.

Identification & Billing

NDC Package Code
67046-1624-3
Package Description
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
67046-1624
11-Digit Billing Format
67046162403
RxNorm Crosswalk
RxCUI: 1656340 - sacubitril 24 MG / valsartan 26 MG Oral Tablet

Clinical Specifications

Proprietary Name
Sacubitril And Valsartan
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
Sacubitril and valsartan tablets are contraindicated:in patients with hypersensitivity to any componentin patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions (5.2)]with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions (7.1)]with concomitant use of aliskiren in patients with diabetes [see Drug Interactions (7.1)]

Regulatory & Marketing

Labeler Name
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213682
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-16-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67046-1624-3 identifies a specific commercial package of 30 tablet, film coated in 1 blister pack of Sacubitril And Valsartan, a human prescription drug labeled by Coupler Llc. 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 Coupler Llc on December 16, 2025. The current certification is valid through December 31, 2027.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046162403. 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)
67046-1624-3
11-Digit CMS (5-4-2)
67046-1624-03

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