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Mirtazapine Tablets

[18 July 2014]

Products Affected - Description

Mirtazapine tablets, Apotex
15 mg, 1000 count (NDC 60505-0247-08)
30 mg, 30 count (NDC 60505-0248-01)
30 mg, 1000 count (NDC 60505-0248-08)
45 mg, 30 count (NDC 60505-0249-01)
45 mg, 1000 count (NDC 60505-0249-08)
 
Mirtazapine tablets, Aurobindo
7.5 mg, 30 count (NDC 13107-0001-30)

 
Mirtazapine tablets, Greenstone
15 mg, 30 count (NDC 59762-1416-03) - discontinued
15 mg, 60 count (NDC 59762-1416-06) - discontinued
15 mg, 90 count (NDC 59762-1416-09) - discontinued
15 mg, 500 count (NDC 59762-1416-05) - discontinued
30 mg, 30 count (NDC 59762-1417-03) - discontinued
30 mg, 60 count (NDC 59762-1417-06) - discontinued
30 mg, 90 count (NDC 59762-1417-09) - discontinued
30 mg, 500 count (NDC 59762-1417-05) - discontinued
45 mg, 30 count (NDC 59762-1418-03) - discontinued
45 mg, 60 count (NDC 59762-1418-06) - discontinued
45 mg, 90 count (NDC 59762-1418-09) - discontinued
45 mg, 500 count (NDC 59762-1418-05) - discontinued

Mirtazapine oral disintegrating tablets, Greenstone
15 mg, 30 count, unit dose (NDC 59762-1410-07) - discontinued
30 mg, 30 count, unit dose (NDC 59762-1412-07) - discontinued
45 mg, 30 count, unit dose (NDC 59762-1414-07) - discontinued 
 
Mirtazapine tablets, Sandoz
15 mg, 30 count (NDC 00185-0020-30) - discontinued
15 mg, 1000 count (NDC 00185-0020-10) - discontinued
30 mg, 30 count (NDC 00185-0212-30) - discontinued
30 mg, 1000 count (NDC 00185-0212-10) - discontinued
45 mg, 30 count (NDC 00185-0222-30) - discontinued
45 mg, 1000 count (NDC 00185-0222-10) - discontinued

Reason for the Shortage

  • Actavis (Watson) cannot provide a reason for the shortage.
  • Actavis discontinued their mirtazapine 15 mg oral disintegrating tablets in May 2014.
  • Greenstone discontinued all remaining mirtazapine presentations in December 2013.
  • Sandoz discontinued their mirtazapine presentations in early-2014.
  • Teva discontinued various unit dose presentations throughout 2013, including mirtazapine. Teva could not provide a reason for the shortage. 

Available Products

Mirtazapine tablets, Actavis (Watson)
15 mg, 30 count (NDC 00591-1117-30)
15 mg, 1000 count (NDC 00591-1117-10)
30 mg, 30 count (NDC 00591-1118-30)
30 mg, 1000 count (NDC 00591-1118-10)
45 mg, 30 count (NDC 00591-1119-30)

Mirtazapine oral disintegrating tablets, Actavis (Watson)
15 mg, 30 count, unit dose (NDC 00591-2230-15) - discontinued
30 mg, 30 count, unit dose (NDC 00591-2470-15)
 
Mirtazapine tablets, Apotex
15 mg, 30 count (NDC 60505-0247-01)

Mirtazapine tablets, Aurobindo
7.5 mg, 500 count (NDC 13107-0001-05)
15 mg, 30 count (NDC 13107-0031-34)
30 mg, 30 count (NDC 13107-0003-34)
30 mg, 500 count (NDC 13107-0003-05)
45 mg, 30 count (NDC 13107-0032-34)
45 mg, 500 count (NDC 13107-0032-05)
 
Mirtazapine tablets, Mylan
15 mg, 30 count (NDC 00378-3515-93)
15 mg, 1000 count (NDC 00378-3515-10)
30 mg, 30 count (NDC 00378-3530-93)
30 mg, 500 count (NDC 00378-3530-05)
45 mg, 30 count (NDC 00378-3545-93)
45 mg, 500 count (NDC 00378-3545-05)
 
Mirtazapine tablets, Teva
15 mg, 30 count (NDC 00093-7206-56) 
30 mg, 30 count (NDC 00093-7207-56)
45 mg, 30 count (NDC 00093-7208-56)
 
Mirtazapine oral disintegrating tablets, Teva
15mg, 30 count, unit dose (NDC 00093-7303-65)
30 mg, 30 count, unit dose (NDC 00093-7304-65)
45 mg, 30 count, unit dose (NDC 00093-7305-65)
 
Mirtazapine tablets, Mylan Institutional
15 mg, 100 count, unit dose (NDC 51079-0086-20)
15 mg, 300 count, unit dose (NDC 51079-0086-56)
30 mg, 100 count, unit dose (NDC 51079-0087-20)
30 mg, 300 count, unit dose (NDC 51079-0087-56)
45 mg, 300 count, unit dose (NDC 51079-0088-56)
45 mg, 100 count, unit dose (NDC 51079-0088-20)

Remeron tablets, Merck
15 mg, 30 count (NDC 00052-0105-30)
30 mg, 30 count (NDC 00052-0107-30)
45 mg, 30 count (NDC 00052-0109-30)

Remeron oral disintegrating tablets, Merck
15 mg, 30 count, unit dose (NDC 00052-0106-30)
30 mg, 30 count, unit dose (NDC 00052-0108-30)
45 mg, 30 count, unit dose (NDC 00052-0110-30)

Estimated Resupply Dates

  • Apotex has most mirtazapine presentations on allocation.
  • Aurobindo has mirtazapine 7.5 mg in 30 count on back order and the company estimates a release date in mid-July 2014.

Related Shortages

Updated

July 18, 2014; June 19, 2014; June 5, 2014; May 22, 2014; April 24, 2014; April 10, 2014; February 27, 2014; January 17, 2014; January 16, 2014; December 20, 2013; November 25, 2013; November 15, 2013; October 31, 2013, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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