Naloxone Hcl Powder
NDC Package 49812-0195-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Naloxone Hcl powders is a medication used to treat known or suspected opioid overdose. This formulation utilizes a powder delivery system. Marketed by Veranova, L.p., this product is identified by NDC 49812-0195.

Identification & Billing

NDC Package Code
49812-0195-1
Package Description
1 CONTAINER in 1 CONTAINER / 1 kg in 1 CONTAINER
Product Code
49812-0195
11-Digit Billing Format
49812019501

Clinical Specifications

Proprietary Name
Naloxone Hcl
Non-Proprietary Name
Naloxone Hcl
Substance Name
Naloxone
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
NALOXONE 1 kg/kg
Usage Information
This medication is used to treat known or suspected opioid overdose. Serious overdose symptoms may include unusual sleepiness, unusual difficulty waking up, or breathing problems (ranging from slow/shallow breathing to no breathing). Other symptoms of overdose may include very small "pinpoint" pupils, slow heartbeat, or low blood pressure. If someone has serious overdose symptoms but you are not sure if he or she has overdosed, give this medication right away anyway, since lasting slow/shallow breathing may cause permanent damage to the brain or death. Naloxone belongs to a class of drugs known as opioid antagonists. It works by blocking the effects of the opioid in the brain. This medication may not work as well to block the effects of certain types of opioids (mixed agonist/antagonists such as buprenorphine, pentazocine). With these types of opioids, blocking may be incomplete or you may need a higher dose of naloxone. Treatment of opioid overdose should also include breathing treatment (such as oxygen given through tubes in the nose, mechanical ventilation, artificial respiration).

Regulatory & Marketing

Labeler Name
Veranova, L.p.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-2012
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 49812-0195-1 identifies a specific commercial package of 1 container in 1 container / 1 kg in 1 container of Naloxone Hcl (UNFINISHED drug), a bulk ingredient labeled by Veranova, L.p.. This powder is formulated for use and contains naloxone 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 Veranova, L.p. on January 01, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat known or suspected opioid overdose. Serious overdose symptoms may include unusual sleepiness, unusual difficulty waking up, or breathing problems (ranging from slow/shallow breathing to no breathing). Other symptoms of overdose may include very small "pinpoint" pupils, slow heartbeat, or low blood pressure. If someone has serious overdose symptoms but you are not sure if he or she has overdosed, give this medication right away anyway, since lasting slow/shallow breathing may cause permanent damage to the brain or death. Naloxone belongs to a class of drugs known as opioid antagonists. It works by blocking the effects of the opioid in the brain. This medication may not work as well to block the effects of certain types of opioids (mixed agonist/antagonists such as buprenorphine, pentazocine). With these types of opioids, blocking may be incomplete or you may need a higher dose of naloxone. Treatment of opioid overdose should also include breathing treatment (such as oxygen given through tubes in the nose, mechanical ventilation, artificial respiration).

How is this Veranova, L.p. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49812019501. 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)
49812-0195-1
11-Digit CMS (5-4-2)
49812-0195-01

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