Oxycodone Hydrochloride
NDC Package 31722-110-01

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.

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; andOpioid-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. Marketed by Camber Pharmaceuticals, Inc., this product is identified by NDC 31722-110 and is authorized under FDA application NDA022272.

Identification & Billing

NDC Package Code
31722-110-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
31722-110
11-Digit Billing Format
31722011001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

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; andOpioid-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
Camber Pharmaceuticals, Inc.
FDA Application #
NDA022272
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-23-2020
End Marketing Date
01-31-2024
Listing Expiration
01-31-2024
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 31722-110-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Oxycodone Hydrochloride, labeled by Camber Pharmaceuticals, 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 Camber Pharmaceuticals, Inc. on December 23, 2020. The current certification is valid through January 31, 2024.

How is this Camber Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 31722011001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
31722-110-01
11-Digit CMS (5-4-2)
31722-0110-01

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