Oxycodone Hydrochloride
NDC Package 17856-0023-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 oral Solution is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions (5.4)] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)] • Hypersensitivity to oxycodone (e.g., angioedema) [see Adverse Reactions (6)]. Marketed by Altantic Biologicals Corp, this product is identified by NDC 17856-0023 and is authorized under FDA application ANDA209897.

Identification & Billing

NDC Package Code
17856-0023-2
Package Description
60 SYRINGE in 1 BOX, UNIT-DOSE / .125 mL in 1 SYRINGE
Product Code
17856-0023
11-Digit Billing Format
17856002302
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 Oral Solution is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions (5.4)] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)] • Hypersensitivity to oxycodone (e.g., angioedema) [see Adverse Reactions (6)]

Regulatory & Marketing

Labeler Name
Altantic Biologicals Corp
FDA Application #
ANDA209897
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2018
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (17856-0023). Click a package code to view its specific billing and regulatory data.

17856-0023-1
60 SYRINGE in 1 BOX, UNIT-DOSE / .5 mL in 1 SYRINGE
17856-0023-3
120 SYRINGE in 1 BOX, UNIT-DOSE / 1 mL in 1 SYRINGE
17856-0023-4
60 SYRINGE in 1 BOX, UNIT-DOSE / 1 mL in 1 SYRINGE
17856-0023-5
120 SYRINGE in 1 BOX, UNIT-DOSE / .25 mL in 1 SYRINGE
17856-0023-6
60 SYRINGE in 1 BOX, UNIT-DOSE / .25 mL in 1 SYRINGE

* 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 17856-0023-2 identifies a specific commercial package of 60 syringe in 1 box, unit-dose / .125 ml in 1 syringe of Oxycodone Hydrochloride, labeled by Altantic Biologicals Corp. 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 Altantic Biologicals Corp on June 01, 2018. The current certification is valid through December 31, 2024.

How is this Altantic Biologicals Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856002302. 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)
17856-0023-2
11-Digit CMS (5-4-2)
17856-0023-02

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