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FDA shortage status: Sterile Water Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2021-11-23. Latest FDA row update: 2026-09-22.
FDA lists 12 package records, with companies: Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., Hospira, Inc., Hospira, Inc., a Pfizer Company, Medefil, Inc., Nephron Pharmaceuticals Corporation. Package NDCs: 0409-3977-03, 0409-4887-10, 0409-4887-20, 0409-4887-50, 0409-4887-99, 0487-6105-01, 0641-6147-10, 63323-178-76, 63323-185-10, 63323-185-20, 63323-185-50, 64253-020-30.
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 |
|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 63323-185-10 | Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-10) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-185-20 | Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-20) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-185-50 | Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-50) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-178-76 | Sterile Water, Injection, 1000 mL/1000 mL (NDC 63323-178-76) | Available | 2026-09-15 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6147-10 | Sterile Water, Injection, 1 mL/1 mL (NDC 0641-6147-10) | Available | 2026-09-18 |
| Hospira, Inc., a Pfizer Company | 0409-3977-03 | Bacteriostatic Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 0409-3977-03) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-4887-10 | Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-10) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-4887-20 | Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-20) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-4887-50 | Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-50) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-4887-99 | Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-99) | Available | 2026-09-22 |
| Medefil, Inc. | 64253-020-30 | Sterile Water, Injection, 10 mL/10 mL (NDC 64253-020-30) | Available | 2026-09-15 |
| Nephron Pharmaceuticals Corporation | 0487-6105-01 | Sterile Water, Injection, 1 mL/1 mL (NDC 0487-6105-01) | Limited Availability | 2026-08-04 |
Source facts
Grouped generic ingredient: Sterile Water Injection · 12 package records
Therapeutic categories: Other
Dosage forms: Injection
Routes: INTRAMUSCULAR, 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.