Zurnai Injection, Solution
NDC Package 59011-962-01

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

Package Information

Zurnai (nalmefene hydrochloride) injection is zURNAI is indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.ZURNAI is intended for immediate administration as emergency therapy in settings where opioids may be present.ZURNAI is not a substitute for emergency medical care. This formulation utilizes a injection, solution delivery system. Marketed by Knoa Pharma Llc, this product is identified by NDC 59011-962 and is authorized under FDA application NDA218590.

Identification & Billing

NDC Package Code
59011-962-01
Package Description
1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS
Product Code
59011-962
11-Digit Billing Format
59011096201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zurnai
Non-Proprietary Name
Nalmefene Hydrochloride
Substance Name
Nalmefene Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
NALMEFENE HYDROCHLORIDE 1.5 mg/.5mL
Pharmacologic Class
Usage Information
ZURNAI is indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.ZURNAI is intended for immediate administration as emergency therapy in settings where opioids may be present.ZURNAI is not a substitute for emergency medical care.

Regulatory & Marketing

Labeler Name
Knoa Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
NDA218590
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-07-2025
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 59011-962-01 identifies a specific commercial package of 1 syringe, glass in 1 carton / .5 ml in 1 syringe, glass of Zurnai, a human prescription drug labeled by Knoa Pharma Llc. This injection, solution is formulated for intramuscular; subcutaneous use and contains nalmefene 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 Knoa Pharma Llc on August 07, 2025. The current certification is valid through December 31, 2027.

How is this Knoa Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59011096201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
59011-962-01
11-Digit CMS (5-4-2)
59011-0962-01

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