NDC 63304-400 Oxycodone Hcl Controlled-release

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
63304-400
Proprietary Name:
Oxycodone Hcl Controlled-release
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Ranbaxy Pharmaceuticals Inc
Labeler Code:
63304
Start Marketing Date: [9]
02-01-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
OC;10
Score:
1

Product Packages

NDC Code 63304-400-01

Package Description: 100 TABLET in 1 BOTTLE

Product Details

What is NDC 63304-400?

The NDC code 63304-400 is assigned by the FDA to the product Oxycodone Hcl Controlled-release which is product labeled by Ranbaxy Pharmaceuticals Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 63304-400-01 100 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Oxycodone Hcl Controlled-release?

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.)

Which are Oxycodone Hcl Controlled-release UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Oxycodone Hcl Controlled-release Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Oxycodone Hcl Controlled-release?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".