Naloxone Hydrochloride Spray
NDC Package 72162-2376-2
Package Information
Naloxone Hydrochloride sprays is emergency Treatment of Opioid OverdoseImportant:•For use in the nose only •Do not test nasal spray device before use •1 nasal spray device contains 1 dose of medicine •Each device sprays 1 time onlyDo not test nasal spray device before use 1 nasal spray device contains 1 dose of medicine Each device sprays 1 time onlyStep 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 well• yell “Wake up!”• shake the person gently• if the person is not awake, go to Step 2Step 2: GIVE 1st dose in the nose• HOLD the nasal spray device with your thumb on the bottom of the plunger• INSERT the nozzle into either NOSTRIL• PRESS the plunger firmly to give the 1st dose• 1 nasal spray device contains 1 doseStep 3: CALL• CALL 911immediately after giving the 1st doseStep 4: WATCH & GIVE• WAIT2-3 minutes after the 1st dose 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 GIVE doses every 2-3 minutes until the person wakes up• it is safe to keep giving dosesStep 5: STAY• STAY until ambulance arrives: even if the person wakes up• GIVE another dose if the person becomes very sleepy again• You may need to give all the doses in the packFor opioid emergencies, call 911. This formulation utilizes a spray delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 72162-2376 and is authorized under FDA application ANDA211951.
Identification & Billing
- RxCUI: 1725059 - naloxone HCl 4 MG in 0.1 ML Nasal Spray
- RxCUI: 1725059 - naloxone hydrochloride 40 MG/ML Nasal Spray
- RxCUI: 1725059 - naloxone HCl 4 MG per 0.1 ML Nasal Spray
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 72162 - Bryant Ranch Prepack
- 72162-2376 - Naloxone Hydrochloride
- 72162-2376-2 - 2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE (72162-2376-4)
- 72162-2376 - Naloxone Hydrochloride
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 72162-2376-2 identifies a specific commercial package of 2 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose (72162-2376-4) of Naloxone Hydrochloride, a human over the counter drug labeled by Bryant Ranch Prepack. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Bryant Ranch Prepack on July 30, 2023. The current certification is valid through December 31, 2026.
How is this Bryant Ranch Prepack product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 72162237602. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
