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Sotalol Hydrochloride

Last Updated: September 2, 2010
Status: Resolved

Products Affected - Description

Sotalol Hydrochloride
Sotalol hydrochloride, Apotex
80 mg, package of 100 (NDC 60505-0080-00)
120 mg, package of 100 (NDC 60505-0159-00)
160 mg, package of 100 (NDC 60505-0081-00)
240 mg, package of 100 (NDC 60505-0082-00)

 
Sotalol hydrochloride, Global Pharmaceuticals
80 mg, package of 100 (NDC 00115-2711-01) — discontinued
120 mg, package of 100 (NDC 00115-2722-01) — discontinued
160 mg, package of 100 (NDC 00115-2733-01) — discontinued
 
Sotalol hydrochloride, Sorine, Upsher-Smith
80 mg, package of 100 (NDC 00245-0012-11) — discontinued
120 mg, package of 100 (NDC 00245-0013-11) — discontinued
160 mg, package of 100 (NDC 00245-0014-11) — discontinued
240 mg, package of 100 (NDC 00245-0015-11) — discontinued
 
Sotalol hydrochloride, Par
80 mg, package of 100 (NDC 49884-0582-01) — discontinued
80 mg, package of 1000 (NDC 49884-0582-10) — discontinued
120 mg, package of 100 (NDC 49884-0583-01) — discontinued
120 mg, package of 1000 (NDC 49884-0583-10) — discontinued
160 mg, package of 100 (NDC 49884-0584-01) — discontinued 
 
Sotalol Hydrochloride AF
Sotalol hydrochloride AF, Amneal
80 mg, package of 100 (NDC 65162-0725-10) — discontinued
120 mg, package of 100 (NDC 65162-0727-10) — discontinued
160 mg, package of 100 (NDC 65162-0731-10) — discontinued
 
Sotalol hydrochloride AF, Apotex
80 mg, package of 100 (NDC 60505-0222-01)
120 mg, package of 100 (NDC 60505-0223-01)
160 mg, package of 100 (NDC 60505-0224-01)

Reason for the Shortage

  • Apotex has an import ban on all of their solid presentations including sotalol tablets.
  • Amneal, Global Pharmaceuticals, Upsher-Smith, and Par have discontinued their products.

Estimated Resupply Dates

  • Mylan has available all presentations of sotalol hydrochloride and sotalol hydrochloride AF including sotalol hydrochloride 80 mg (NDC 00378-0305-01), 120 mg (NDC 00378-0310-01), and 160 mg (NDC 00378-0314-01) tablets in 100 count bottles and sotalol hydrochloride AF 80 mg (NDC 00378-5123-01), 120 mg (NDC 00378-5124-01), and 160 mg (NDC 00378-5125-01) tablets in 100 count bottles.
  • Bayer has available all presentations of Betapace and Betapace AF including Betapace 80 mg (NDC 50419-0105-10), 120 mg (NDC 50419-0109-10), and 160 mg (NDC 50419-0106-10) tablets in 100 count bottles and Betapace AF 80 mg (NDC 50419-0115-06), 120 mg (NDC 50419-0119-06), and 160 mg (NDC 50419-0116-06) caplets in 60 count bottles.
  • Qualitest has available all presentations of sotalol hydrochloride including 80 mg 100 count unit dose (NDC 00603-5769-21) and 500 count unit dose tablets (NDC 00603-5769-28), 120 mg (NDC 00603-5770-21), and 160 mg (NDC 00603-5771-21) tablets in 100 count unit dose packages.
  • Sandoz has available all presentations including 80 mg 100 count (NDC 00185-0171-01), 80 mg 500 count (NDC 00185-0171-05), 120 mg 100 count (NDC 00185-0170-01), 160 mg 100 count (NDC 00185-0177-01), and 240 mg tablets in 100 count (NDC 00185-0174-01) bottles.
  • Amneal has discontinued all Sotalol AF presentations.
  • Upsher-Smith has available all presentations of Sorine including 80 mg (NDC 00245-0012-01), 120 mg (NDC 00245-0013-01), 160 mg (NDC 00245-0014-01), and 240 mg (NDC 00245-0015-01) tablets in 100 count unit dose packages.
  • Teva has available sotalol hydrochloride 80 mg (NDC 00093-1061-01), 120 mg (NDC 00093-1060-01), and 160 mg (NDC 00093-1062-01), and 240 mg (NDC 00093-1063-01) tablets in 100 count bottles.

Related Shortages

Updated

September 2, 2010; July 7, 2010; May 12, 2010; March 31, 2010; January 29, 2010, University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.

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