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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Methotrexate Sodium Injection
Status: Currently in Shortage
»Date first posted: 03/13/2023
»Therapeutic Categories: Rheumatology; Oncology

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Accord Healthcare Inc. (Revised 11/18/2024)

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

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-30) Unavailable, 30 - 60 Days Currently in production at plant Shortage of an active ingredient
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-35) Unavailable, 30 - 60 Days Currently in production at plant Shortage of an active ingredient

Fresenius Kabi USA, LLC (Reverified 11/19/2024)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methotrexate Preservative Free, Injection, 1 g (NDC 63323-122-50) Available Check wholesaler for inventory
Injection, 25 mg/1 mL (NDC 63323-123-10) Available Check whlolesaler for inventory

Hikma Pharmaceuticals USA, Inc. (Reverified 11/25/2024)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methotrexate Injection, USP Preservative Free, Injection, 1 g (NDC 0143-9830-01) Available Currently available. Additional product will be made available as it is released.
Methotrexate Injection,USP Preservative Free, Injection, 25 mg/1 mL (NDC 0143-9519-10) Available Additional lots are scheduled to be manufactured. Product will be made available as it is released.

Hospira, Inc., a Pfizer Company (Revised 11/12/2024)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methotrexate, Injection, 50 mg/2 mL (25 mg/mL) (NDC 61703-350-38) Available
Methotrexate, Injection, 50 mg/2 mL (25 mg/mL) (NDC 61703-350-10) Available
Methotrexate, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-41) Available
Methotrexate, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-25) Available
Methotrexate, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-124-40) Available

Teva Pharmaceuticals USA, Inc. (Revised 11/26/2024)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3671-01) Limited Availability March 2025 Demand increase for the drug
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3675-01) Limited Availability November 2025 Demand increase for the drug
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3678-01) Limited Availability Estimated recovery March 2025 Demand increase for the drug
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