Oxycodone Hcl Controlled-release
NDC Package 63304-401-01

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.

Oxycodone Hcl Controlled-release is tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic.Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society.Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Marketed by Ranbaxy Pharmaceuticals Inc, this product is identified by NDC 63304-401 and is authorized under FDA application NDA020553.

Identification & Billing

NDC Package Code
63304-401-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
63304-401
11-Digit Billing Format
63304040101
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: 1049502 - oxyCODONE HCl 10 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1049502 - 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet
  • RxCUI: 1049502 - oxycodone hydrochloride 10 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 1049563 - oxyCODONE HCl 20 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1049563 - 12 HR oxycodone hydrochloride 20 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Oxycodone Hcl Controlled-release
Dosage Form
-
Usage Information
Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic.Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society.Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

Regulatory & Marketing

Labeler Name
Ranbaxy Pharmaceuticals Inc
FDA Application #
NDA020553
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2010
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 63304-401-01 identifies a specific commercial package of 100 tablet in 1 bottle of Oxycodone Hcl Controlled-release, labeled by Ranbaxy Pharmaceuticals Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. 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 Ranbaxy Pharmaceuticals Inc on February 01, 2010. The current certification is valid through December 31, 2017.

How is this Ranbaxy Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304040101. 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)
63304-401-01
11-Digit CMS (5-4-2)
63304-0401-01

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