Oxycodone Hydrochloride
NDC Package 16590-835-90

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 iNDICATIONS AND USAGEOxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. Marketed by Stat Rx Llc Usa, this product is identified by NDC 16590-835 and is authorized under FDA application ANDA078206.

Identification & Billing

NDC Package Code
16590-835-90
Package Description
90 TABLET in 1 BOTTLE
Product Code
16590-835
11-Digit Billing Format
16590083590
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxycodone Hydrochloride
Dosage Form
-
Usage Information
INDICATIONS AND USAGEOxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

Regulatory & Marketing

Labeler Name
Stat Rx Llc Usa
FDA Application #
ANDA078206
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-30-2009
Listing Expiration
12-31-2017
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 (16590-835). Click a package code to view its specific billing and regulatory data.

16590-835-30
30 TABLET in 1 BOTTLE
16590-835-45
45 TABLET in 1 BOTTLE
16590-835-50
50 TABLET in 1 BOTTLE
16590-835-56
56 TABLET in 1 BOTTLE
16590-835-60
60 TABLET in 1 BOTTLE
16590-835-72
120 TABLET in 1 BOTTLE
16590-835-75
75 TABLET in 1 BOTTLE

* 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 16590-835-90 identifies a specific commercial package of 90 tablet in 1 bottle of Oxycodone Hydrochloride, labeled by Stat Rx Llc Usa. 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 Stat Rx Llc Usa on July 30, 2009. The current certification is valid through December 31, 2017.

How is this Stat Rx Llc Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590083590. 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)
16590-835-90
11-Digit CMS (5-4-2)
16590-0835-90

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