Opana Er
NDC Package 21695-948-60

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.

Opana Er is oxymorphone extended-release is used to help relieve severe ongoing pain. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-948 and is authorized under FDA application NDA021610.

Identification & Billing

NDC Package Code
21695-948-60
Package Description
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
21695-948
11-Digit Billing Format
21695094860
RxNorm Crosswalk
  • RxCUI: 977874 - oxyMORphone HCl 10 MG 12HR Extended Release Oral Tablet
  • RxCUI: 977874 - 12 HR oxymorphone hydrochloride 10 MG Extended Release Oral Tablet
  • RxCUI: 977874 - oxymorphone hydrochloride 10 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 977876 - OPANA ER 10 MG 12HR Extended Release Oral Tablet
  • RxCUI: 977876 - 12 HR oxymorphone hydrochloride 10 MG Extended Release Oral Tablet [Opana]

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
Rebel Distributors Corp
FDA Application #
NDA021610
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-22-2006
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21695-948-60 identifies a specific commercial package of 60 tablet, film coated, extended release in 1 bottle of Opana Er, labeled by Rebel Distributors 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 Rebel Distributors Corp on June 22, 2006. The current certification is valid through December 31, 2017.

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 Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695094860. 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)
21695-948-60
11-Digit CMS (5-4-2)
21695-0948-60

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