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  4. NDC Product Code: 76420-867 Naloxone Hydrochloride

NDC 76420-867 Naloxone Hydrochloride

Spray, Metered Nasal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 76420-867?
  4. Naloxone Hydrochloride Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Get all the details for National Drug Code (NDC) 76420-867 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
76420-867
Proprietary Name:
Naloxone Hydrochloride
Non-Proprietary Name: [1]
Naloxone Hydrochloride
Substance Name: [2]
Naloxone Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
Nasal - Administration to the nose; administered by way of the nose.
Labeler Name: [5]
Asclemed Usa, Inc.
Labeler Code:
76420
Product Label ID:
7acf3bde-f858-4fbc-8a11-6741a3d27b8e
FDA Application Number: [6]
ANDA209522
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
09-23-2024
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
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Product Details

What is NDC 76420-867?

The NDC code 76420-867 is assigned by the FDA to the product Naloxone Hydrochloride which is a human over the counter drug product labeled by Asclemed Usa, Inc.. The product's dosage form is spray, metered and is administered via nasal form. The product is distributed in a single package with assigned NDC code 76420-867-02 2 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack / .1 ml in 1 vial, single-dose. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Naloxone Hydrochloride?

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

What are Naloxone Hydrochloride Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • NALOXONE HYDROCHLORIDE 4 mg/.1mL - A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.

Which are Naloxone Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Naloxone Hydrochloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Naloxone Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes for Naloxone Hydrochloride?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Naloxone Nasal Spray


Prescription and nonprescription (over the counter) naloxone nasal spray is used along with emergency medical treatment to reverse the life-threatening effects of a known or suspected opiate (narcotic) overdose in adults and children. Naloxone nasal spray is in a class of medications called opiate antagonists. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".