Neffy Spray
NDC Package 82580-010-02

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

Package Information

Neffy (epinephrine) sprays is a medication used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. This formulation utilizes a spray delivery system. Marketed by Ars Pharmaceuticals Operations, Inc., this product is identified by NDC 82580-010 and is authorized under FDA application NDA214697.

Identification & Billing

NDC Package Code
82580-010-02
Package Description
2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / 100 uL in 1 VIAL, SINGLE-DOSE
Product Code
82580-010
11-Digit Billing Format
82580001002
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
Neffy
Non-Proprietary Name
Epinephrine
Substance Name
Epinephrine
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)
EPINEPHRINE 1 mg/100uL
Pharmacologic Class
Usage Information
This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

Regulatory & Marketing

Labeler Name
Ars Pharmaceuticals Operations, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214697
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-05-2025
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 82580-010-02 identifies a specific commercial package of 2 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack / 100 ul in 1 vial, single-dose of Neffy, a human prescription drug labeled by Ars Pharmaceuticals Operations, Inc.. This spray is formulated for nasal use and contains epinephrine 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 Ars Pharmaceuticals Operations, Inc. on March 05, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

How is this Ars Pharmaceuticals Operations, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82580001002. 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)
82580-010-02
11-Digit CMS (5-4-2)
82580-0010-02

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