Opana Er
NDC Package 63629-4174-2

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 discontinued by the firm.

Opana Er is oxymorphone extended-release is used to help relieve severe ongoing pain. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-4174 and is authorized under FDA application NDA021610.

Identification & Billing

NDC Package Code
63629-4174-2
Package Description
30 TABLET in 1 BOTTLE
Product Code
63629-4174
11-Digit Billing Format
63629417402

Clinical Specifications

Proprietary Name
Opana Er
Dosage Form
-
Usage Information
Oxymorphone extended-release is used to help relieve severe ongoing pain. It belongs to a class of drugs known as long-acting opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the extended-release form of oxymorphone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
FDA Application #
NDA021610
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-31-2010
End Marketing Date
01-03-2019
Listing Expiration
01-03-2019
Exclude Flag
D
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 (63629-4174). Click a package code to view its specific billing and regulatory data.

63629-4174-1
60 TABLET in 1 BOTTLE
63629-4174-3
90 TABLET in 1 BOTTLE
63629-4174-4
56 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 63629-4174-2 identifies a specific commercial package of 30 tablet in 1 bottle of Opana Er, labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on December 31, 2010. The current certification is valid through January 03, 2019.

What are the primary indications for this medication?

Oxymorphone extended-release is used to help relieve severe ongoing pain. It belongs to a class of drugs known as long-acting opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the extended-release form of oxymorphone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629417402. 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)
63629-4174-2
11-Digit CMS (5-4-2)
63629-4174-02

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