Naloxone Hydrochloride Spray, Metered
NDC Package 0591-3871-99

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:CHECK for a suspected overdose: the person will not wake up or is very sleepy or not breathing wellyell “Wake up!”shake the person gentlyif the person is not awake, go to Step 2 Step 2: GIVE 1stdose in the noseHOLD the nasal spray device with your thumb on the bottom of the plungerINSERT the nozzle into either NOSTRILPRESS the plunger firmly to give the 1st dose1 nasal spray device contains 1 dose Step 3: CALLCALL 911immediately after giving the 1st doseStep 4: WATCH & GIVEWAIT2-3 minutes after the 1stdose to give the medicine time to workif the person wakes up: Go to Step 5if the person does not wake up:CONTINUE TO GIVE doses every 2-3 minutes until the person wakes upit is safe to keep giving dosesStep 5: STAYSTAY until ambulance arrives: even if the person wakes upGIVE another dose if the person becomes very sleepy againYou may need to give all the doses in the pack. This formulation utilizes a spray, metered delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-3871 and is authorized under FDA application ANDA209522.

Identification & Billing

NDC Package Code
0591-3871-99
Package Description
2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-3871-54) / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code
0591-3871
11-Digit Billing Format
00591387199
RxNorm Crosswalk

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:CHECK for a suspected overdose: the person will not wake up or is very sleepy or not breathing wellyell “Wake up!”shake the person gentlyif the person is not awake, go to Step 2 Step 2: GIVE 1stdose in the noseHOLD the nasal spray device with your thumb on the bottom of the plungerINSERT the nozzle into either NOSTRILPRESS the plunger firmly to give the 1st dose1 nasal spray device contains 1 dose Step 3: CALLCALL 911immediately after giving the 1st doseStep 4: WATCH & GIVEWAIT2-3 minutes after the 1stdose to give the medicine time to workif the person wakes up: Go to Step 5if the person does not wake up:CONTINUE TO GIVE doses every 2-3 minutes until the person wakes upit is safe to keep giving dosesStep 5: STAYSTAY until ambulance arrives: even if the person wakes upGIVE another dose if the person becomes very sleepy againYou may need to give all the doses in the pack

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA209522
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-17-2025
Listing Expiration
12-31-2026
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 0591-3871-99 identifies a specific commercial package of 2 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack (0591-3871-54) / .1 ml in 1 vial, single-dose of Naloxone Hydrochloride, a human over the counter drug labeled by Actavis Pharma, Inc.. 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 Actavis Pharma, Inc. on January 17, 2025. The current certification is valid through December 31, 2026.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591387199. 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 (4-4-2)
0591-3871-99
11-Digit CMS (5-4-2)
00591-3871-99

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