Rezenopy Spray
NDC Package 83245-003-01

11-digit billing NDC: 83245000301 · Billing unit: EA · 2 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Rezenopy (naloxone hcl) sprays is 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. This formulation utilizes a spray delivery system. Marketed by Scienture Llc, this product is identified by NDC 83245-003 and is authorized under FDA application NDA215487.

Identification & Billing

NDC Package Code
83245-003-01
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
83245-003
11-Digit Billing Format
83245000301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rezenopy
Non-Proprietary Name
Naloxone Hcl
Substance Name
Naloxone Hydrochloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
NALOXONE HYDROCHLORIDE 10 mg/.11mL
Pharmacologic Class
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
Scienture Llc
Product Type
Human Prescription Drug
FDA Application #
NDA215487
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-29-2026
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 83245-003-01 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, a human prescription drug labeled by Scienture Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This spray is formulated for nasal use and contains naloxone hydrochloride 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 Scienture Llc on January 29, 2026. The current certification is valid through December 31, 2027.

How is this Scienture Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83245000301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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)
83245-003-01
11-Digit CMS (5-4-2)
83245-0003-01

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