Opvee Spray
NDC Package 12496-0003-2

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

Package Information

Opvee (nalmefene hydrochloride) sprays is oPVEE nasal spray is indicated for the emergency treatment of known or suspected 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.OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.OPVEE nasal spray is not a substitute for emergency medical care. This formulation utilizes a spray delivery system. Marketed by Indivior Inc., this product is identified by NDC 12496-0003 and is authorized under FDA application NDA217470.

Identification & Billing

NDC Package Code
12496-0003-2
Package Description
2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (12496-0003-1) / 100 uL in 1 VIAL, SINGLE-DOSE
Product Code
12496-0003
11-Digit Billing Format
12496000302
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
Opvee
Non-Proprietary Name
Nalmefene Hydrochloride
Substance Name
Nalmefene 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)
NALMEFENE HYDROCHLORIDE 2.7 mg/100uL
Pharmacologic Class
Usage Information
OPVEE nasal spray is indicated for the emergency treatment of known or suspected 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.OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.OPVEE nasal spray is not a substitute for emergency medical care.

Regulatory & Marketing

Labeler Name
Indivior Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA217470
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-02-2023
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 12496-0003-2 identifies a specific commercial package of 2 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack (12496-0003-1) / 100 ul in 1 vial, single-dose of Opvee, a human prescription drug labeled by Indivior Inc.. This spray is formulated for nasal 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 Indivior Inc. on October 02, 2023. The current certification is valid through December 31, 2027.

How is this Indivior Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12496000302. 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 (5-4-1)
12496-0003-2
11-Digit CMS (5-4-2)
12496-0003-02

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