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FDA shortage status: Methotrexate Sodium Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2023-03-13. Latest FDA row update: 2026-10-03.
FDA lists 14 package records, with companies: Accord Healthcare Inc., Accord Healthcare, Inc., Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., Hospira, Inc., Hospira, Inc., a Pfizer Company, Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc.. Package NDCs: 0143-9519-10, 0143-9830-01, 0703-3671-01, 0703-3675-01, 0703-3678-01, 16729-277-30, 16729-277-35, 61703-124-40, 61703-350-10, 61703-350-38, 61703-408-25, 61703-408-41, 63323-122-50, 63323-123-10.
FDA shortage reason: Demand increase for the drug; Other
This is nationwide FDA status, not local pharmacy inventory. CiteFacts does not provide medical, treatment, substitution, or dosing advice.
FDA package and manufacturer records
| Company | Package NDC | Presentation | FDA availability field | FDA update |
|---|---|---|---|---|
| Accord Healthcare Inc. | 16729-277-30 | Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-30) | Unavailable | 2026-10-03 |
| Accord Healthcare Inc. | 16729-277-35 | Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-35) | Unavailable | 2026-10-03 |
| Fresenius Kabi USA, LLC | 63323-122-50 | Methotrexate Preservative Free, Injection, 1 g (NDC 63323-122-50) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-123-10 | Methotrexate Sodium, Injection, 25 mg/1 mL (NDC 63323-123-10) | Available | 2026-09-15 |
| Hikma Pharmaceuticals USA, Inc. | 0143-9830-01 | Methotrexate, Preservative Free, Injection, 1 g (NDC 0143-9830-01) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0143-9519-10 | Methotrexate, Preservative Free, Injection, 25 mg/1 mL (NDC 0143-9519-10) | Unavailable | 2026-09-18 |
| Hospira, Inc., a Pfizer Company | 61703-124-40 | Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-124-40) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 61703-408-25 | Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-25) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 61703-408-41 | Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-41) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 61703-350-10 | Methotrexate Sodium, Injection, 50 mg/2 mL (25 mg/mL) (NDC 61703-350-10) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 61703-350-38 | Methotrexate Sodium, Injection, 50 mg/2 mL (25 mg/mL) (NDC 61703-350-38) | Available | 2026-09-22 |
| Teva Pharmaceuticals USA, Inc. | 0703-3671-01 | Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3671-01) | Limited Availability | 2026-10-01 |
| Teva Pharmaceuticals USA, Inc. | 0703-3675-01 | Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3675-01) | Limited Availability | 2026-10-01 |
| Teva Pharmaceuticals USA, Inc. | 0703-3678-01 | Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3678-01) | Limited Availability | 2026-10-01 |
Source facts
Grouped generic ingredient: Methotrexate Sodium Injection · 14 package records
Therapeutic categories: Oncology, Rheumatology
Dosage forms: Injection
Routes: INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, SUBCUTANEOUS
Open FDA source data · JSON · Markdown
FDA is authoritative. Source retrieved 2026-10-06T18:55:41+00:00. Derived grouping is documented in this record's derivations.