NDC 63304-222 Oxymorphone Hydrochloride

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:
63304-222
Proprietary Name:
Oxymorphone Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Ranbaxy Pharmaceuticals Inc.
Labeler Code:
63304
Start Marketing Date: [9]
04-13-2015
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328 - PINK TO LIGHT PINK)
GRAY (C48324 - GRAY TO LIGHT GRAY)
ORANGE (C48331 - ORANGE TO LIGHT ORANGE)
WHITE (C48325 - WHITE TO OFF-WHITE)
GREEN (C48329 - GREEN TO LIGHT GREEN)
Shape:
ROUND (C48348)
Size(s):
9 MM
Imprint(s):
RH29
RI36
RH30
RI37
RH31
Score:
1

Product Packages

NDC Code 63304-222-05

Package Description: 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC Code 63304-222-30

Package Description: 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 63304-222?

The NDC code 63304-222 is assigned by the FDA to the product Oxymorphone Hydrochloride which is product labeled by Ranbaxy Pharmaceuticals Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 63304-222-05 500 tablet, film coated, extended release in 1 bottle , 63304-222-30 30 tablet, film coated, extended release 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 Oxymorphone Hydrochloride?

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.

Which are Oxymorphone Hydrochloride UNII Codes?

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

Which are Oxymorphone Hydrochloride 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 Oxymorphone Hydrochloride?

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: 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

* 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".