Oxycodone Hydrochloride Solution
NDC Package 67296-2167-6

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

Package Information

Oxycodone Hydrochloride solution is oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. This formulation utilizes a solution delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2167 and is authorized under FDA application NDA200535.

Identification & Billing

NDC Package Code
67296-2167-6
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 60 mL in 1 BOTTLE, PLASTIC
Product Code
67296-2167
11-Digit Billing Format
67296216706

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride
Non-Proprietary Name
Oxycodone Hydrochloride
Substance Name
Oxycodone Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXYCODONE HYDROCHLORIDE 5 mg/5mL
Pharmacologic Class
Usage Information
Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
NDA200535
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-09-2013
Listing Expiration
12-31-2026
Exclude Flag
N
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 67296-2167-6 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 60 ml in 1 bottle, plastic of Oxycodone Hydrochloride, a human prescription drug labeled by Redpharm Drug. This solution is formulated for oral use and contains oxycodone hydrochloride 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 Redpharm Drug on September 09, 2013. The current certification is valid through December 31, 2026.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296216706. 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)
67296-2167-6
11-Digit CMS (5-4-2)
67296-2167-06

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