NDC Package 63304-218-05 Oxymorphone Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63304-218-05
Package Description:
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Oxymorphone Hydrochloride
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.Limitations of UsageBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.
11-Digit NDC Billing Format:
63304021805
NDC to 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
  • Labeler Name:
    Ranbaxy Pharmaceuticals Inc.
    Sample Package:
    No
    Start Marketing Date:
    04-13-2015
    Listing Expiration Date:
    12-31-2018
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    63304-218-3030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63304-218-05?

    The NDC Packaged Code 63304-218-05 is assigned to a package of 500 tablet, film coated, extended release in 1 bottle of Oxymorphone Hydrochloride, labeled by Ranbaxy Pharmaceuticals Inc.. The product's dosage form is and is administered via form.

    Is NDC 63304-218 included in the NDC Directory?

    No, Oxymorphone Hydrochloride with product code 63304-218 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Ranbaxy Pharmaceuticals Inc. on April 13, 2015 and its listing in the NDC Directory is set to expire on December 31, 2018 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 63304-218-05?

    The 11-digit format is 63304021805. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263304-218-055-4-263304-0218-05