Evzio
NDC Package 60842-030-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Evzio is a medication used for the emergency treatment of known or suspected opioid overdose. Marketed by Kaleo, Inc., this product is identified by NDC 60842-030 and is authorized under FDA application NDA205787.

Identification & Billing

NDC Package Code
60842-030-01
Package Description
2 INJECTION, SOLUTION in 1 CARTON
Product Code
60842-030
11-Digit Billing Format
60842003001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Evzio
Dosage Form
-
Usage Information
This medication is used for the emergency treatment of 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. This medication 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. The effects of naloxone will not last as long as the effects of the opioid. Since treatment with this medication is not long-lasting, be sure to get medical help right away after giving the first 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
Kaleo, Inc.
FDA Application #
NDA205787
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-03-2014
End Marketing Date
05-31-2018
Listing Expiration
05-31-2018
Exclude Flag
D
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 60842-030-01 identifies a specific commercial package of 2 injection, solution in 1 carton of Evzio, labeled by Kaleo, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Kaleo, Inc. on April 03, 2014. The current certification is valid through May 31, 2018.

What are the primary indications for this medication?

This medication is used for the emergency treatment of 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. This medication 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. The effects of naloxone will not last as long as the effects of the opioid. Since treatment with this medication is not long-lasting, be sure to get medical help right away after giving the first 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 Kaleo, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60842003001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
60842-030-01
11-Digit CMS (5-4-2)
60842-0030-01

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