Oxycodone
NDC Package 67877-623-91

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Oxycodone is hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.  Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:  Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia . Marketed by Ascend Laboratories, Llc, this product is identified by NDC 67877-623 and is authorized under FDA application ANDA211748.

Identification & Billing

NDC Package Code
67877-623-91
Package Description
500 mL in 1 BOTTLE, PLASTIC
Product Code
67877-623
11-Digit Billing Format
67877062391
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxycodone
Dosage Form
-
Usage Information
Oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.  Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:  Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia 

Regulatory & Marketing

Labeler Name
Ascend Laboratories, Llc
FDA Application #
ANDA211748
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-09-2019
Listing Expiration
12-31-2024
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67877-623). Click a package code to view its specific billing and regulatory data.

67877-623-19
15 mL in 1 BOTTLE, PLASTIC
67877-623-88
100 mL in 1 BOTTLE, PLASTIC

* 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 67877-623-91 identifies a specific commercial package of 500 ml in 1 bottle, plastic of Oxycodone, labeled by Ascend Laboratories, Llc. 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 Ascend Laboratories, Llc on February 09, 2019. The current certification is valid through December 31, 2024.

How is this Ascend Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67877062391. 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)
67877-623-91
11-Digit CMS (5-4-2)
67877-0623-91

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