Oxycodone Hydrochloride
NDC Package 17856-0393-1

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 solution USP, 100 mg per 5 mL ( ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. Marketed by Atlantic Biologicals Corps, this product is identified by NDC 17856-0393 and is authorized under FDA application ANDA203208.

Identification & Billing

NDC Package Code
17856-0393-1
Package Description
1 mL in 1 SYRINGE, PLASTIC
Product Code
17856-0393
11-Digit Billing Format
17856039301
RxNorm Crosswalk
  • RxCUI: 1049615 - oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral Solution
  • RxCUI: 1049615 - oxycodone hydrochloride 20 MG/ML Oral Solution
  • RxCUI: 1049615 - oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral Solution

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride
Dosage Form
-
Usage Information
Oxycodone Hydrochloride Solution USP, 100 mg per 5 mL ( ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. Oral20 mg/mLOxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL (20 mg/mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer.

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corps
FDA Application #
ANDA203208
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2015
Listing Expiration
12-31-2018
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 17856-0393-1 identifies a specific commercial package of 1 ml in 1 syringe, plastic of Oxycodone Hydrochloride, labeled by Atlantic Biologicals Corps. 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 Atlantic Biologicals Corps on January 01, 2015. The current certification is valid through December 31, 2018.

How is this Atlantic Biologicals Corps product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856039301. 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)
17856-0393-1
11-Digit CMS (5-4-2)
17856-0393-01

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