Oxymorphone Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 64896-697-01

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

Oxymorphone Hydrochloride tablets is oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 64896-697 and is authorized under FDA application ANDA079087.

Identification & Billing

NDC Package Code
64896-697-01
Package Description
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
64896-697
11-Digit Billing Format
64896069701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
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: 977894 - oxyMORphone HCl 15 MG 12HR Extended Release Oral Tablet
  • RxCUI: 977894 - 12 HR oxymorphone hydrochloride 15 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Oxymorphone Hydrochloride
Non-Proprietary Name
Oxymorphone Hydrochloride
Substance Name
Oxymorphone Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXYMORPHONE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA079087
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-02-2013
Listing Expiration
12-31-2027
Exclude Flag
N
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 (64896-697). Click a package code to view its specific billing and regulatory data.

64896-697-03
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
64896-697-08
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
64896-697-13
60 TABLET, FILM COATED, EXTENDED RELEASE 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 64896-697-01 identifies a specific commercial package of 100 tablet, film coated, extended release in 1 bottle of Oxymorphone Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This tablet, film coated, extended release is formulated for oral use and contains oxymorphone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Llc on January 02, 2013. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64896069701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
64896-697-01
11-Digit CMS (5-4-2)
64896-0697-01

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