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FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Naltrexone Hydrochloride Tablet
Status: Currently in Shortage
»Date first posted: 02/29/2024
»Therapeutic Categories: Analgesia/Addiction

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Accord Healthcare Inc. (Revised 04/02/2025)

Company Contact Information:
866-941-7875, option 2

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 16729-081-01) Unavailable Estimated recovery: 60 Days Shortage of an active ingredient
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 16729-081-10) Limited Availability 14 days Shortage of an active ingredient

Chartwell Molecular Holdings LLC (Reverified 03/24/2025)

Company Contact Information:
845-268-5000 Ext. 510

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 62135-242-60) Available

Elite Laboratories, Inc. (Reverified 04/01/2025)

Company Contact Information:
800-397-9228

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 51224-206-50) Available Marketed by Tagi Pharma
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 51224-206-30) Available Marketed by Tagi Pharma
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 68094-909-50) Available Marketed by Precision Dose
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 68094-909-30) Available Marketed by Precision Dose

SpecGx LLC (Reverified 04/01/2025)

Company Contact Information:
800-325-8888

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 0406-1170-01) Limited Availability Long term allocations to primary customers with intermittent backorder expected through 2025. Demand increase for the drug
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 0406-1170-03) Limited Availability Long term allocations to primary customers with intermittent backorder expected through 2025. Demand increase for the drug

Sun Pharmaceutical Industries, Inc. (Revised 04/04/2025)

Company Contact Information:
800-818-4555

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 47335-326-88) Limited Availability Q2 2025 Demand increase for the drug
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 47335-326-83) Limited Availability Q2 2025 Demand increase for the drug
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 47335-326-08) Unavailable Currently not marketed Other
Naltrexone Hydrochloride, Tablet, 50 mg (NDC 47335-326-18) Unavailable Currently not marketed Other
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