Oxycodone Hydrochloride Oral Solution
NDC Package 13107-261-58

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

Package Information

Oxycodone Hydrochloride Oral Solution solution is 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. This formulation utilizes a solution delivery system. Marketed by Aurolife Pharma, Llc, this product is identified by NDC 13107-261 and is authorized under FDA application ANDA212429.

Identification & Billing

NDC Package Code
13107-261-58
Package Description
1 BOTTLE in 1 CARTON / 500 mL in 1 BOTTLE
Product Code
13107-261
11-Digit Billing Format
13107026158
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride Oral Solution
Non-Proprietary Name
Oxycodone Hydrochloride Oral Solution
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 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 patients. Limitations of UseBecause 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
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Aurolife Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212429
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-27-2020
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 13107-261-58 identifies a specific commercial package of 1 bottle in 1 carton / 500 ml in 1 bottle of Oxycodone Hydrochloride Oral Solution, a human prescription drug labeled by Aurolife Pharma, Llc. 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 Aurolife Pharma, Llc on January 27, 2020. The current certification is valid through December 31, 2026.

How is this Aurolife Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13107026158. 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)
13107-261-58
11-Digit CMS (5-4-2)
13107-0261-58

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