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
Accord Healthcare Inc. (Revised 04/16/2024)
| 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, 75 days | Fresh Resupply under manufacturing; Some Short dated inventory available | Requirements related to complying with good manufacturing practices |
| Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-35) | Unavailable, 75 days | Fresh Resupply under manufacturing; Some Short dated inventory available | Requirements related to complying with good manufacturing practices |
Fresenius Kabi USA, LLC (Reverified 04/16/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Methotrexate Preservative Free, Injection, 1 g (NDC 63323-122-50) | Available | Available. Check wholesaler for inventory | |
| Injection, 25 mg/1 mL (NDC 63323-123-10) | Available | Available. Check wholesaler for inventory. |
Hikma Pharmaceuticals USA, Inc. (Reverified 04/23/2024)
| 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 03/28/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Methotrexate, Injection, 25 mg/1 mL (NDC 61703-350-38) | Limited Availability | Limited Supply Available. Next Delivery: March 2024; Estimated Recovery: September 2024; Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Demand increase for the drug |
| Methotrexate, Injection, 25 mg/1 mL (NDC 61703-350-10) | Limited Availability | Limited Supply Available. Next Delivery: July 2024; Estimated Recovery: September 2024; Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Demand increase for the drug |
| Methotrexate, Injection, 25 mg/1 mL (NDC 61703-408-41) | Available | ||
| Methotrexate, Injection, 25 mg/1 mL (NDC 61703-408-25) | Available | ||
| Methotrexate, Injection, 25 mg/1 mL (NDC 61703-124-40) | Limited Availability | Limited Supply Available. Next Delivery: August 2024; Estimated Recovery: September 2024; Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Demand increase for the drug |
Teva Pharmaceuticals USA, Inc. (Revised 02/06/2024)
| 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) | Available | ||
| Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3675-01) | Available | ||
| Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3678-01) | Available |