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Irbesartan Tablets

Last Updated: January 27, 2023
Status: Current

Products Affected - Description
    • Avapro oral tablet, Sanofi-Aventis, 150 mg, bottle, 30 count, NDC 00024-5851-30
    • Irbesartan oral tablet, Camber, 150 mg, bottle, 30 count, NDC 31722-0730-30
    • Irbesartan oral tablet, Camber, 150 mg, bottle, 90 count, NDC 31722-0730-90
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 30 count, NDC 31722-0731-30
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 90 count, NDC 31722-0731-90
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 90 count, NDC 31722-0162-05
    • Irbesartan oral tablet, Camber, 75 mg, bottle, 30 count, NDC 31722-0729-30
    • Irbesartan oral tablet, Camber, 75 mg, bottle, 90 count, NDC 31722-0729-90
    • Irbesartan oral tablet, Lupin, 150 mg, bottle, 30 count, NDC 68180-0411-06 - discontinued
    • Irbesartan oral tablet, Lupin, 150 mg, bottle, 90 count, NDC 68180-0411-09 - discontinued
    • Irbesartan oral tablet, Lupin, 300 mg, bottle, 30 count, NDC 59746-0449-30 - discontinued
    • Irbesartan oral tablet, Lupin, 300 mg, bottle, 90 count, NDC 59746-0449-90 - discontinued
    • Irbesartan oral tablet, Lupin, 75 mg, bottle, 30 count, NDC 68180-0410-06 - discontinued
    • Irbesartan oral tablet, Lupin, 75 mg, bottle, 90 count, NDC 68180-0410-09 - discontinued
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 30 count, NDC 43547-0278-03
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 90 count, NDC 43547-0278-09
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 500 count, NDC 43547-0375-50
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 500 count, NDC 43547-0278-50
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 30 count, NDC 43547-0279-03
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 90 count, NDC 43547-0279-09
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 500 count, NDC 43547-0376-50
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 500 count, NDC 43547-0279-50
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 30 count, NDC 43547-0277-03
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 90 count, NDC 43547-0277-09
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 500 count, NDC 43547-0374-50
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 500 count, NDC 43547-0277-50
Reason for the Shortage
    • Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards. Additional information including a list of affected lots can be found at https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan.
    • Solco and ScieGen were affected by the recall.
    • Camber did not provide a reason for the shortage.
    • Lupin has discontinued irbesartan tablets.
    • Hikma and Westminster are not actively marketing irbesartan tablets.
    • MacLeod's has irbesartan tablets available to contracted customers only.
    • Sanofi-Aventis did not provide a reason for the shortage.
    • Winthrop did not provide availability information. Check with your wholesaler for availability.
    • Repackagers may have some presentations affected depending on the source supplier.
Available Products
    • Avapro oral tablet, Sanofi-Aventis, 300 mg, bottle, 30 count, NDC 00024-5852-30
    • Avapro oral tablet, Sanofi-Aventis, 75 mg, bottle, 90 count, NDC 00024-5850-90
    • Irbesartan oral tablet, Alembic, 150 mg, bottle, 30 count, NDC 62332-0042-30
    • Irbesartan oral tablet, Alembic, 150 mg, bottle, 90 count, NDC 62332-0042-90
    • Irbesartan oral tablet, Alembic, 150 mg, bottle, 500 count, NDC 62332-0042-71
    • Irbesartan oral tablet, Alembic, 300 mg, bottle, 30 count, NDC 62332-0043-30
    • Irbesartan oral tablet, Alembic, 300 mg, bottle, 90 count, NDC 62332-0043-90
    • Irbesartan oral tablet, Alembic, 300 mg, bottle, 500 count, NDC 62332-0043-71
    • Irbesartan oral tablet, Alembic, 75 mg, bottle, 30 count, NDC 62332-0041-30
    • Irbesartan oral tablet, Alembic, 75 mg, bottle, 90 count, NDC 62332-0041-90
    • Irbesartan oral tablet, Macleods, 150 mg, bottle, 30 count, NDC 33342-0048-07
    • Irbesartan oral tablet, Macleods, 150 mg, bottle, 90 count, NDC 33342-0048-10
    • Irbesartan oral tablet, Macleods, 300 mg, bottle, 30 count, NDC 33342-0049-07
    • Irbesartan oral tablet, Macleods, 300 mg, bottle, 90 count, NDC 33342-0049-10
    • Irbesartan oral tablet, Macleods, 75 mg, bottle, 30 count, NDC 33342-0047-07
    • Irbesartan oral tablet, Macleods, 75 mg, bottle, 90 count, NDC 33342-0047-10
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 30 count, NDC 43547-0375-03
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 90 count, NDC 43547-0375-09
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 30 count, NDC 43547-0376-03
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 90 count, NDC 43547-0376-09
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 30 count, NDC 43547-0374-03
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 90 count, NDC 43547-0374-09
    • Irbesartan oral tablet, Winthrop, 150 mg, bottle, 90 count, NDC 00955-1041-90
    • Irbesartan oral tablet, Winthrop, 300 mg, bottle, 90 count, NDC 00955-1042-90
    • Irbesartan oral tablet, Winthrop, 75 mg, bottle, 90 count, NDC 00955-1040-90

Estimated Resupply Dates

    • Camber has irbesartan tablets on allocation.
    • Solco has several irbesartan 75 mg, 150 mg, and 300 mg tablets on back order and the company cannot estimate a release date.
    • Sanofi-Aventis has Avapro 150 mg tablets available with short expiration dating (December 2023).

Updated

Updated January 27, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. Created July 19, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.