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10/2/2025

Acamprosate Calcium Tablets

Products Affected - Description

    • Acamprosate calcium oral tablet, Glenmark, 333 mg, bottle, 180 count, NDC 68462-0435-18
    • Acamprosate calcium oral tablet, Zydus, 333 mg, bottle, 180 count, NDC 68382-0569-28

Reason for the Shortage

    • Glenmark states the reason for the shortage is regulatory issues.
    • Viatris has acamprosate tablets available.
    • Zydus did not provide a reason for the shortage.

Available Products

    • Acamprosate calcium oral tablet, Mylan (Viatris), 333 mg, bottle, 180 count, NDC 00378-6333-80

Estimated Resupply Dates

    • Glenmark has acamprosate 333 mg tablets on back order and the company estimates a release date of late-October 2025.
    • Zydus has acamprosate 333 mg tablets temporarily discontinued.

Implications for Patient Care

    • This drug is used to maintain abstinence from alcohol in patients who are in a comprehensive management program.[1-2]

Safety

    • Acamprosate should be used in patients who have stopped drinking alcohol.[1-2]
    • Monitor patients for depression and suicidal ideations while taking acamprosate.[1-2]
    • Continue taking acamprosate if relapse occurs and contact your healthcare provider.[1-2]

Alternative Agents & Management

    • Alternative agents approved to treat alcohol use disorder include disulfiram (200 mg daily by mouth) and naltrexone.[3]
    • Naltrexone is available as oral tablets (50 mg daily) or intramuscular injection (380 mg monthly).[3]

References

    1. Acamprosate calcium delayed-release tablets [prescribing information]. Morgantown, WV IL: Mylan Pharmaceuticals; November 2022.
    2. Acamprosate. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed September 1, 2025.
    3. Haber PS. Identification and treatment of alcohol use disorder. N Engl J Med 2025;392:258-66.

Updated

Updated October 2, 2025 by Rachael Freeman, PharmD, BCPS. Created September 30, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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