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Oxymorphone Hydrochloride

Last Updated: June 20, 2013
Status: Resolved

Products Affected - Description

Extended-Release Presentations
Opana ER, Endo
5 mg tablets, 100 count (NDC 63481-0907-70) - discontinued
5 mg tablets, 100 count (NDC 63481-0434-70) - discontinued
10 mg tablets, 100 count (NDC 63481-0674-70) - discontinued
10 mg tablets, 100 count (NDC 63481-0436-70) - discontinued
20 mg tablets, 100 count (NDC 63481-0617-70) - discontinued
20 mg tablets, 100 count (NDC 63481-0438-70) - discontinued
30 mg tablets, 100 count (NDC 63481-0571-70) - discontinued
30 mg tablets, 100 count (NDC 63481-0439-70) - discontinued
40 mg tablets, 100 count (NDC 63481-0693-70) - discontinued
40 mg tablets, 100 count (NDC 63481-0440-70) - discontinued

Immediate-Release Presentations
Oxymorphone immediate-release tablets

Reason for the Shortage

  • Novartis voluntarily suspended all manufacturing and distribution from its Lincoln, Nebraska facility in early-January 2012 due to a potential for mixing of different products within a single bottle. Novartis is gradually resuming manufacturing at this facility after manufacturing improvements were implemented.
  • Several Endo products that are manufactured at the Lincoln, Nebraska plant, are affected by this manufacturing suspension, including oxymorphone, Opana, and Opana ER.
  • Endo introduced new crush proof Opana ER tablets in late 2012. There are all new NDC numbers for these products. The NDC numbers for Opana ER with the older formulation have been discontinued.
  • Roxane could not provide a reason for this shortage.
  • Global Pharma introduced oxymorphone ER tablets in January, 2013. These tablets are not AB rated to the currently marketed Opana ER tablets.
  • KVK Tech launched oxycodone 5 mg and 10 mg immediate release tablets in 2013.

Available Products

Extended-Release Presentations

Oxymorphone extended-release, Actavis
7.5 mg tablets, 100 count (NDC 00228-3261-11)
15 mg tablets, 100 count (NDC 00228-3262-11)
 
Opana ER crush proof tablets, Endo
5 mg tablets, 60 count (NDC 63481-0812-60)
7.5 mg tablets, 60 count (NDC 63481-0813-60)
10 mg tablets, 60 count (NDC 63481-0814-60)
15 mg tablets, 60 count (NDC 63481-0815-60)
20 mg tablets, 60 count (NDC 63481-0816-60)
30 mg tablets, 60 count (NDC 63481-0817-60)
40 mg tablets, 60 count (NDC 63481-0818-60)

Oxymorphone extended release tablets, Global Pharma
5 mg tablets, 60 count (NDC 00115-1231-13)
7.5 mg tablets, 60 count (NDC 00115-1315-13)
10 mg tablets, 60 count (NDC 00115-1232-13)
15 mg tablets, 60 count (NDC 00115-1316-13)
20 mg tablets, 60 count (NDC 00115-1233-13)
40 mg tablets, 60 count (NDC 00115-1234-13)
5 mg tablets, 100 count (NDC 00115-1231-01)
7.5 mg tablets, 100 count (NDC 00115-1315-01)
10 mg tablets, 100 count (NDC 00115-1232-01)
15 mg tablets, 100 count (NDC 00115-1316-01)
20 mg tablets, 100 count (NDC 00115-1233-01)
30 mg tablets, 100 count (NDC 00115-0317-01)
40 mg tablets, 100 count (NDC 00115-1234-01)
 
Immediate-Release Presentations
Opana, Endo
5 mg tablets, 100 count (NDC 63481-0612-70)
10 mg tablets, 100 count (NDC 63481-0613-70)
 
Oxymorphone, KVK Tech
5 mg tablets, 100 count (NDC 10702-0070-01)
10 mg tablets, 100 count (NDC 10702-0071-01)
 
Oxymorphone, Qualitest
5 mg tablets, 100 count (NDC 60951-0794-70)
10 mg tablets, 100 count (NDC 60951-0795-70)
 
Oxymorphone, Roxane
5 mg tablets, 100 count (NDC 00054-0283-25)
10 mg tablets, 100 count (NDC 00054-0284-25)

Estimated Resupply Dates

Extended-Release Presentations

  • All presentations are available.
Immediate-Release Presentations
  • All presentations are available.

Related Shortages

Updated

June 20, 2013; May 15, 2013; April 29, 2013; April 19, 2013; March 21, 2013; February 22, 2013; February 6, 2013; January 16, 2013; January 2, 2013; October 15, 2012; August 22, 2012; June 25, 2012; May 15, 2012; May 1, 2012; April 11, 2012; March 13, 2012; March 1, 2012; February 24, 2012; January 12, 2012, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.

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