Naloxone Hydrochloride Spray
NDC Package 69238-2104-7

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 overdoseCHECK 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 2Step 2: GIVE 1st dose 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 doseStep 3: CALL 911CALL 911 immediately after giving the 1st doseStep 4: WATCH & GIVEWAIT 2 to 3 minutes after the 1st dose 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 to 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 Naloxone Hydrochloride Nasal Spray, 4 mg Emergency Treatment of Opioid OverdoseImportant:For use in the nose onlyDo not test nasal spray device before use1 nasal spray device contains 1 dose of medicineEach device sprays 1 time onlyStep 1: CHECK if you suspect an overdoseCHECK 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 2Step 2: GIVE 1st dose 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 doseStep 3: CALL 911CALL 911 immediately after giving the 1st doseStep 4: WATCH & GIVEWAIT 2 to 3 minutes after the 1st dose 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 to 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 packFor opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact Amneal Pharmaceuticals at 1-877-835-5472. This formulation utilizes a spray delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-2104 and is authorized under FDA application ANDA217992.

Identification & Billing

NDC Package Code
69238-2104-7
Package Description
2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE (69238-2104-1)
Product Code
69238-2104
11-Digit Billing Format
69238210407
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naloxone Hydrochloride
Non-Proprietary Name
Naloxone Hydrochloride
Substance Name
Naloxone 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)
NALOXONE HYDROCHLORIDE 4 mg/.1mL
Pharmacologic Class
Usage Information
Step 1: CHECK if you suspect an overdoseCHECK 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 2Step 2: GIVE 1st dose 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 doseStep 3: CALL 911CALL 911 immediately after giving the 1st doseStep 4: WATCH & GIVEWAIT 2 to 3 minutes after the 1st dose 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 to 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 Naloxone Hydrochloride Nasal Spray, 4 mg Emergency Treatment of Opioid OverdoseImportant:For use in the nose onlyDo not test nasal spray device before use1 nasal spray device contains 1 dose of medicineEach device sprays 1 time onlyStep 1: CHECK if you suspect an overdoseCHECK 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 2Step 2: GIVE 1st dose 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 doseStep 3: CALL 911CALL 911 immediately after giving the 1st doseStep 4: WATCH & GIVEWAIT 2 to 3 minutes after the 1st dose 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 to 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 packFor opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact Amneal Pharmaceuticals at 1-877-835-5472. Rev. 07-2023-04

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Otc Drug
FDA Application #
ANDA217992
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-24-2024
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 69238-2104-7 identifies a specific commercial package of 2 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose (69238-2104-1) of Naloxone Hydrochloride, a human over the counter drug labeled by Amneal Pharmaceuticals Ny Llc. This spray 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 Amneal Pharmaceuticals Ny Llc on April 24, 2024. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238210407. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
69238-2104-7
11-Digit CMS (5-4-2)
69238-2104-07

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