Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Dexamethasone Sodium Phosphate Injection
Status: Currently in Shortage
»Date first posted:
02/08/2019
»Therapeutic Categories: Dermatology; Endocrinology/Metabolism; Gastroenterology; Hematology; Neurology; Oncology; Ophthalmology; Other; Pulmonary/Allergy; Rheumatology
Eugia Pharma Specialties LTD. (formerly Aurobindo) (Revised 03/17/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 4 mg/1 mL SDV (NDC 55150-237-01) | On long-term backorder | Check wholesalers for inventory | Demand increase for the drug |
| 20 mg/5 mL MDV (NDC 55150-238-05) | On long-term backorder | Check wholesalers for inventory | Demand increase for the drug |
| 120 mg/30 mL MDV (NDC 55150-239-30) | Currently on backorder - next shipment end of March 2023 | Check wholesalers for inventory | Demand increase for the drug |
| 10 mg/1 mL SDV (NDC 55150-304-25) | Currently on backorder - next shipment end of March 2023 | Check wholesalers for inventory | Demand increase for the drug |
| 100 mg/10 mL MDV (contains preservative)(NDC 55150-305-10) | Available | Check wholesalers for inventory | Demand increase for the drug |
Fresenius Kabi USA, LLC (Revised 03/10/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 4 mg per 1 mL, Single dose Simplist syringe, preservative free (NDC 76045-106-10) | 7 month expiry (10/31/2023 expiry) dating available by request. | Check wholesalers for inventory. | Increase in demand |
| 10 mg per 1 mL, Single dose Simplist syringe, preservative free (NDC 76045-109-10) | Available | Check wholesalers for inventory. | Increase in demand |
| 20 mg per 5 mL (4 mg per mL); MDV; Amber vial (NDC 63323-165-05) | Available | Check wholesalers for inventory. | Increase in demand |
| 100 mg per 10 mL (10 mg per mL); MDV; Amber Vial (NDC 63323-516-10) | Available | Check wholesalers for inventory. | Increase in demand |
| 120 mg per 30 mL (4 mg per mL); MDV; Amber Vial (NDC 63323-165-30) | Backordered. Next release March 2023. | Increase in demand | |
| 4 mg per mL (4 mg per mL); SDV; Amber Vial (NDC 63323-165-01) | Available | Check wholesalers for inventory. | Increase in demand |
| 10 mg per mL (10 mg per mL); SDV; Preservative Free; Amber Vial (NDC 63323-506-01) | Available | Check wholesalers for inventory. | Increase in demand |
Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 10/13/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 4 mg/mL, 1 mL vial (NDC 0641-6145-25) | Inventory is currently available | Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. | Other |
| 4 mg/mL, 5 mL vial (NDC 0641-6146-25) | Inventory is currently available. | Additional lots will be scheduled for manufacturing. Product will be made available as it is released. | Other |
| 10 mg/mL, 1 mL vial (NDC 0641-0367-25) | Inventory is currently available | Additional lots will be scheduled for manufacturing. Product will be made available as it is released. | Other |
Mylan Institutional, a Viatris company (Reverified 03/14/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection SDV [4 mg / 1 ml] 25PK (NDC 67457-423-12) | Available | Demand increase for the drug | |
| Dexamethasone Sodium Phosphate Injection MDV [20 mg / 5 ml] 25PK (NDC 67457-422-54) | Available | Demand increase for the drug | |
| Dexamethasone Sodium Phosphate Injection MDV [120 mg / 30 ml] 25 PK (NDC 67457-421-30) | Available | Demand increase for the drug | |
| Dexamethasone Sodium Phosphate Injection MDV [100 mg / 10 ml] 10PK (NDC 67457-420-10) | Available | Demand increase for the drug |
Somerset Therapeutics, LLC (Reverified 04/20/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL, 1 mL Single Dose Vial (Preservative Free)(NDC 70069-021-25) | Available |