Rezenopy
NDC Package 43674-004-02

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 inactivated by the FDA.

Rezenopy is nasal spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients.REZENOPY nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Marketed by Summit Biosciences Inc, this product is identified by NDC 43674-004 and is authorized under FDA application NDA215487.

Identification & Billing

NDC Package Code
43674-004-02
Package Description
2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .11 mL in 1 VIAL, SINGLE-DOSE
Product Code
43674-004
11-Digit Billing Format
43674000402
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rezenopy
Dosage Form
-
Usage Information
REZENOPY nasal spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients.REZENOPY nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. REZENOPY nasal spray is not a substitute for emergency medical care.

Regulatory & Marketing

Labeler Name
Summit Biosciences Inc
FDA Application #
NDA215487
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-10-2025
Listing Expiration
12-31-2025
Exclude Flag
I
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 43674-004-02 identifies a specific commercial package of 2 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack / .11 ml in 1 vial, single-dose of Rezenopy, labeled by Summit Biosciences 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 Summit Biosciences Inc on February 10, 2025. The current certification is valid through December 31, 2025.

How is this Summit Biosciences Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43674000402. 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)
43674-004-02
11-Digit CMS (5-4-2)
43674-0004-02

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