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  5. NDC Package Code: 51316-210-02 Naloxone Hydrochloride

NDC Package 51316-210-02 Naloxone Hydrochloride

Spray Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
51316-210-02
Package Description:
2 VIAL in 1 CARTON / .1 mL in 1 VIAL (51316-210-01)
Product Code:
51316-210
Proprietary Name:
Naloxone Hydrochloride
Non-Proprietary Name:
Naloxone Hydrochloride
Substance Name:
Naloxone Hydrochloride
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 2 Step 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 dose Step 3: CALL 911CALL 911 immediately after giving the 1st dose Step 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 doses Step 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 mgEmergency 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 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 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 AND 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
11-Digit NDC Billing Format:
51316021002
NDC to RxNorm Crosswalk:
  • RxCUI: 1725059 - naloxone HCl 4 MG per 0.1 ML Nasal Spray
  • RxCUI: 1725059 - naloxone hydrochloride 40 MG/ML Nasal Spray
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Cvs Pharmacy, Inc
    Dosage Form:
    Spray - A liquid minutely divided as by a jet of air or steam.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • NALOXONE HYDROCHLORIDE 4 mg/.1mL
    • Pharmacologic Class(es):
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA217992
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-24-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 51316-210-02?

    The NDC Packaged Code 51316-210-02 is assigned to a package of 2 vial in 1 carton / .1 ml in 1 vial (51316-210-01) of Naloxone Hydrochloride, a human over the counter drug labeled by Cvs Pharmacy, Inc. The product's dosage form is spray and is administered via nasal form.

    Is NDC 51316-210 included in the NDC Directory?

    Yes, Naloxone Hydrochloride with product code 51316-210 is active and included in the NDC Directory. The product was first marketed by Cvs Pharmacy, Inc on April 24, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 51316-210-02?

    The 11-digit format is 51316021002. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-251316-210-025-4-251316-0210-02