Naloxone Hydrochloride Spray, Metered
NDC Package 85766-228-02

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

Package Information

Naloxone Hydrochloride sprays is step 1: CHECK if you suspect an overdose:CHECKfor a suspected overdose:the person will not wake up or is very sleepy or not breathing well yell “Wake up!”shake the person gentlyif the person is not awake, go to Step 2Step 2: GIVE 1 stdose in the nose HOLDthe nasal spray device with your thumb on the bottom of the plunger INSERTthe nozzle into either NOSTRIL PRESSthe plunger firmly to give the 1 stdose 1 nasal spray device contains 1 doseStep 3: CALLCALL 911immediately after giving the 1 stdose Step 4: WATCH & GIVEWAIT2-3 minutes after the 1 stdose to give the medicine time to work if the person wakes up:Go to Step 5 if the person does not wake up:CONTINUE TO GIVEdoses every 2-3 minutes until the person wakes up it is safe to keep giving dosesStep 5: STAYSTAYuntil ambulance arrives: even if the person wakes up GIVEanother dose if the person becomes very sleepy again You may need to give all the doses in the pack. This formulation utilizes a spray, metered delivery system. Marketed by Sportpharm Llc, this product is identified by NDC 85766-228 and is authorized under FDA application ANDA209522.

Identification & Billing

NDC Package Code
85766-228-02
Package Description
2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code
85766-228
11-Digit Billing Format
85766022802

Clinical Specifications

Proprietary Name
Naloxone Hydrochloride
Non-Proprietary Name
Naloxone Hydrochloride
Substance Name
Naloxone Hydrochloride
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
NALOXONE HYDROCHLORIDE 4 mg/.1mL
Pharmacologic Class
Usage Information
Step 1: CHECK if you suspect an overdose:CHECKfor a suspected overdose:the person will not wake up or is very sleepy or not breathing well yell “Wake up!”shake the person gentlyif the person is not awake, go to Step 2Step 2: GIVE 1 stdose in the nose HOLDthe nasal spray device with your thumb on the bottom of the plunger INSERTthe nozzle into either NOSTRIL PRESSthe plunger firmly to give the 1 stdose 1 nasal spray device contains 1 doseStep 3: CALLCALL 911immediately after giving the 1 stdose Step 4: WATCH & GIVEWAIT2-3 minutes after the 1 stdose to give the medicine time to work if the person wakes up:Go to Step 5 if the person does not wake up:CONTINUE TO GIVEdoses every 2-3 minutes until the person wakes up it is safe to keep giving dosesStep 5: STAYSTAYuntil ambulance arrives: even if the person wakes up GIVEanother dose if the person becomes very sleepy again You may need to give all the doses in the pack

Regulatory & Marketing

Labeler Name
Sportpharm Llc
Product Type
Human Otc Drug
FDA Application #
ANDA209522
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-23-2024
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 85766-228-02 identifies a specific commercial package of 2 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack / .1 ml in 1 vial, single-dose of Naloxone Hydrochloride, a human over the counter drug labeled by Sportpharm Llc. This spray, metered 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 Sportpharm Llc on September 23, 2024. The current certification is valid through December 31, 2027.

How is this Sportpharm Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85766022802. 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)
85766-228-02
11-Digit CMS (5-4-2)
85766-0228-02

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