Zynrelef
NDC Package 47426-504-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Zynrelef is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. Marketed by Heron Therapeutics, Inc., this product is identified by NDC 47426-504 and is authorized under FDA application NDA211988.

Identification & Billing

NDC Package Code
47426-504-01
Package Description
1 CARTON in 1 KIT / 1 VIAL, SINGLE-DOSE in 1 CARTON (47426-504-03) / 2.3 mL in 1 VIAL, SINGLE-DOSE
Product Code
47426-504
11-Digit Billing Format
47426050401
RxNorm Crosswalk
  • RxCUI: 2560306 - ZYNRELEF (BUPivacaine 200 MG / meloxicam 6 MG) in 7 ML Extended Release Solution
  • RxCUI: 2560306 - 7 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]
  • RxCUI: 2560306 - Zynrelef (bupivacaine 200 MG / meloxicam 6 MG) per 7 ML Extended Release Solution
  • RxCUI: 2560308 - ZYNRELEF (BUPivacaine 400 MG / meloxicam 12 MG) in 14 ML Extended Release Solution
  • RxCUI: 2560308 - 14 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]

Clinical Specifications

Proprietary Name
Zynrelef
Dosage Form
-
Usage Information
ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.

Regulatory & Marketing

Labeler Name
Heron Therapeutics, Inc.
FDA Application #
NDA211988
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2024
End Marketing Date
12-01-2024
Listing Expiration
12-01-2024
Exclude Flag
D
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 47426-504-01 identifies a specific commercial package of 1 carton in 1 kit / 1 vial, single-dose in 1 carton (47426-504-03) / 2.3 ml in 1 vial, single-dose of Zynrelef, labeled by Heron Therapeutics, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Heron Therapeutics, Inc. on December 01, 2024. The current certification is valid through December 01, 2024.

How is this Heron Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47426050401. 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)
47426-504-01
11-Digit CMS (5-4-2)
47426-0504-01

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