Oxycodone Hydrochloride
NDC Package 67296-1376-2

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 inactivated by the FDA.

Oxycodone Hydrochloride is oXYCODONE HCl EXTENDED-RELEASE TABLETS are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Marketed by Redpharm Drug, Inc., this product is identified by NDC 67296-1376 and is authorized under FDA application NDA022272.

Identification & Billing

NDC Package Code
67296-1376-2
Package Description
20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
67296-1376
11-Digit Billing Format
67296137602
RxNorm Crosswalk
  • RxCUI: 1860157 - oxyCODONE HCl 10 MG 12HR Extended Release Oral Tablet, Abuse-Deterrent
  • RxCUI: 1860157 - Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet
  • RxCUI: 1860157 - oxycodone HCl 10 MG 12 HR Extended Release Oral Tablet, Abuse-Deterrent

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride
Dosage Form
-
Usage Information
OXYCODONE HCl EXTENDED-RELEASE TABLETS are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve OXYCODONE HCl EXTENDED-RELEASE TABLETS for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. OXYCODONE HCl EXTENDED-RELEASE TABLETS are not indicated as an as-needed (prn) analgesic.

Regulatory & Marketing

Labeler Name
Redpharm Drug, Inc.
FDA Application #
NDA022272
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
02-22-2016
Listing Expiration
12-31-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-1376-2 identifies a specific commercial package of 20 tablet, film coated, extended release in 1 bottle of Oxycodone Hydrochloride, labeled by Redpharm Drug, 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 Redpharm Drug, Inc. on February 22, 2016. The current certification is valid through December 31, 2023.

How is this Redpharm Drug, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296137602. 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)
67296-1376-2
11-Digit CMS (5-4-2)
67296-1376-02

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