Oxycodone Combinations Capsules and Tablets

04 January 2010

Products Affected - Description

Oxycodone 2.5 mg/ Acetaminophen 400 mg tablets
Magnacet, 100 count (NDC 23635-0991-01) - discontinued

Oxycodone 5 mg/ Acetaminophen 400 mg tablets
Magnacet, 100 count (NDC 23635-0992-01) - discontinued

Oxycodone 7.5 mg/ Acetaminophen 400 mg tablets
Magnacet, 100 count (NDC 23635-0993-01) - discontinued

Oxycodone 10 mg/ Acetaminophen 400 mg tablets
Magnacet, 100 count (NDC 23635-0994-01) - discontinued

Actavis
100 count (NDC 52152-0041-02) - discontinued
500 count (NDC 52152-0041-04) - discontinued

Reason for the Shortage

• Watson states the shortage is due to supply and demand.
• Mallinckrodt states the shortage is due to a raw material shortage in 2008. The company is now producing product and expects supply to return to normal.
• Mallinckrodt has sold their Magnecet presentations to Victory Pharmaceuticals. The product is not currently available.
• Qualitest could not provide a reason for the shortage. They discontinued 5/500 capsules in 100 count (NDC 00254-4832-28) bottles in April, 2009.
• Athlon Pharmaceuticals discontinued their Perloxx products in June, 2008.
• Actavis discontinued all oxycodone/acetaminophen products in April, 2009.

Estimated Resupply Dates

Oxycodone/acetaminophen products

• Endo had available all Percocet products including 2.5/325 tablets in 100 count (NDC 63481-0627-70), 5/325 tablets in 100 count (NDC 63481-0623-70), 5/325 tablets in 500 count (NDC 63481-0623-85), 5/325 unit-dose tablets in 100 count (NDC 63481-0623-75), 7.5/325 tablets in 100 count (NDC 63481-0628-70), 10/325 tablets in 100 count (NDC 63481-0629-70), 7.5/500 tablets in 100 count (NDC 63481-0621-70), and 10/650 tablets in 100 count (NDC 63481-0622-70).
• Endo had available all Endocet products including 5/325 tablets in 100 count (NDC 60951-0602-70), 5/325 tablets in 500 count (NDC 60951-0602-85), 7.5/325 tablets in 100 count (NDC 60951-0700-70), 10/325 tablets in 100 count (NDC 60951-0712-70), 7.5/500 tablets in 100 count (NDC 60951-0796-70), and 10/650 tablets in 100 count (NDC 60951-0797-70).
• Teva has available oxycodone/acetaminophen 5/500 capsules in 100 count bottles (NDC 00555-0658-02).
• Amneal has available oxycodone/acetaminophen 5/325 tablets in 100 count (NDC 53746-0203-01) and 500 count bottles (NDC53746-0203-05), 7.5/500 tablets in 100 count (NDC 53746-0205-01), and 10/325 in 100 count (NDC 53746-0204-01) bottles, and oxycodone/acetaminophen 10/650 tablets in bottles of 100 count (NDC 53746-0206-01) bottles.
• Ortho-McNeil has available Tylox 5/500 capsules in 100 count bottles (NDC 00045-0526-60) and 100 count unit-dose (NDC 00045-0526-79).
• Roxane has available oxycodone/acetaminophen 5/500 capsules in 100 count bottles (NDC 00054-2795-25).
• Roxane has available Roxicet 5/325 unit-dose tablets in 100 count (NDC 00054-8650-24), 5/325 tablets in 100 count (NDC 00054-4650-25) and 500 count (NDC 00054-4650-29), and 5/500 caplets in 100 count (NDC 00054-4784-25).
• Mallinckrodt has available all oxycodone/acetaminophen presentations including 5/325 tablets in 100 count (NDC 00406-0512-01) and 500 count (NDC 00406-0512-05), 5/325 unit dose tablets in 100 count (NDC 00406-0512-62), 5/500 capsule (NDC 00406-0532-01) in 100 count and 500 count (NDC 00406-0532-05), 7.5/325 caplets in 100 count (NDC 00406-0522-01), 7.5/500 tablets (NDC 00406-0582-01), and10/325 tablets in 100 count (NDC 00406-0523-01) and 100 count unit dose tablets (NDC 00406-0523-62) sizes.
• Qualitest has available their oxycodone/acetaminophen 5/500 capsules in 100 count (NDC 00603-4997-21), 5/325 tablets in 100 count (NDC 00603-4998-21), and 5/325 tablets in 500 count (NDC 00603-4998-28) bottles.
• Watson has available oxycodone/acetaminophen 5/325 tablets in 100 count (NDC 00591-0749-01) and 500 count (NDC 00591-0749-05), 7.5/325 in 100 count (NDC 00591-0933-01), 7.5/500 tablets in 100 count (NDC 00591-0824-01), 10/325 in 100 count (NDC 00591-0932-01), and 10/650 tablets in 100 count (NDC 00591-0825-01) sizes. The 5/500 capsules in 100 count (NDC 00591-0737-01) and 500 count (NDC 00591-0737-05) sizes are available.

Oxycodone/aspirin products

• Endo had available Endodan 4.8355/325 tablets in 100 bottles (NDC 60951-0310-70).
• Endo had available Percodan 4.8355/325 tablets in 100 count bottles (NDC 63481-0121-70).

Oxycodone/ibuprofen products

• Teva has available oxycodone/ibuprofen 5/400 tablets in 100 count bottles (NDC 00555-0778-02).
• Watson has available oxycodone/ibuprofen 5/400 tablets in 100 count bottles (NDC 00591-3494-01).

Related Shortages

• Acetaminophen/dichloralphenazone/isometheptene— Resolved
• Alfentanil Injection— Resolved
• Butorphanol Injection— Resolved
• Choline Magnesium Trisalicylate
• Codeine Phosphate Oral Solution— No Longer Available
• Diazepam Injection— Resolved
• Fentanyl Transdermal System Patch— Resolved
• Hydrocodone Tablets— Resolved
• Hydromorphone Hydrochloride Injection
• Indomethacin Capsules— Resolved
• Indomethacin Injection
• Ketorolac Injection
• Meperidine— Resolved
• Meperidine / Promethazine— No Longer Available
• Methadone Hydrochloride Injection— Resolved
• Methadone Hydrochloride Tablets— Resolved
• Methadone Injection— Resolved
• Methadone Oral Tablets and Liquid— Resolved
• Morphine PCA Syringes— Resolved
• Morphine Sulfate— No Longer Available
• Morphine Sulfate: Extended-Release Products— Resolved
• Morphine Sulfate: Oral Concentrated Solution
• Oxycodone Extended-Release Tablets— Resolved
• Oxycodone Tablets, Capsules, and Solutions
• Pentazocine / Naloxone Tablets
• Remifentanil Hydrochloride— Resolved
• Sufentanil Injection— Resolved

Updated

January 4, 2010; December 17, 2009; November 20, 2009; October 8, 2009; September 3, 2009; August 6, 2009; July 2, 2009; May 13, 2009; April 14, 2009; March 26, 2009; March 4, 2009; February 20, 2009. February 11, 2009, University of Utah, Drug Information Service. Copyright 2010, University of Utah, Drug Information Service.

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