NDC Package 63304-400-01 Oxycodone Hcl Controlled-release

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

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:

63304-400-01

Package Description:

100 TABLET in 1 BOTTLE

Product Code:

63304-400

Proprietary Name:

Oxycodone Hcl Controlled-release

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.)

11-Digit NDC Billing Format:

63304040001

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

100 EA

NDC to 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

Labeler Name:

Ranbaxy Pharmaceuticals Inc

Sample Package:

Start Marketing Date:

02-01-2010

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

63304 - Ranbaxy Pharmaceuticals Inc
- 63304-400 - Oxycodone Hcl Controlled-release
  - 63304-400-01 - 100 TABLET in 1 BOTTLE

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.

Frequently Asked Questions

What is NDC 63304-400-01?

The NDC Packaged Code 63304-400-01 is assigned to a package of 100 tablet in 1 bottle of Oxycodone Hcl Controlled-release, labeled by Ranbaxy Pharmaceuticals Inc. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package.

Is NDC 63304-400 included in the NDC Directory?

No, Oxycodone Hcl Controlled-release with product code 63304-400 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 February 01, 2010 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 63304-400-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 63304-400-01?

The 11-digit format is 63304040001. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	63304-400-01	5-4-2	63304-0400-01

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