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FDA shortage status: Fentanyl Citrate Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2012-01-01. Latest FDA row update: 2026-09-22.
FDA lists 19 package records, with companies: Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., Hospira, Inc., Hospira, Inc., a Pfizer Company. Package NDCs: 0409-9094-22, 0409-9094-25, 0409-9094-28, 0409-9094-31, 0409-9094-61, 0641-6024-10, 0641-6025-10, 0641-6026-05, 0641-6027-25, 0641-6028-25, 0641-6029-25, 0641-6030-01, 0641-6247-25, 63323-806-01, 63323-806-02, 63323-806-05, 63323-806-20, 63323-806-50, 63323-808-11.
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 | 63323-806-01 | Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-01) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-806-02 | Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-02) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-806-05 | Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-05) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-806-20 | Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-20) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-806-50 | Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-50) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-808-11 | Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 63323-808-11) | Available | 2026-09-15 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6027-25 | Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6027-25) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6028-25 | Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6028-25) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6029-25 | Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6029-25) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6030-01 | Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6030-01) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6247-25 | Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6247-25) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6024-10 | Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6024-10) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6025-10 | Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6025-10) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6026-05 | Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6026-05) | Unavailable | 2026-09-18 |
| Hospira, Inc., a Pfizer Company | 0409-9094-22 | Fentanyl Citrate, Injection, 100 mcg/2 mL (50 ug/1 mL) (NDC 0409-9094-22) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-9094-31 | Fentanyl Citrate, Injection, 1000 mcg/20 mL (50 ug/1 mL) (NDC 0409-9094-31) | Limited Availability | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-9094-25 | Fentanyl Citrate, Injection, 250 mcg/5 mL (50 ug/1 mL) (NDC 0409-9094-25) | Limited Availability | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-9094-61 | Fentanyl Citrate, Injection, 2500 mcg/50 mL (50 ug/1 mL) (NDC 0409-9094-61) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-9094-28 | Fentanyl Citrate, Injection, 500 mcg/10 mL (50 ug/1 mL) (NDC 0409-9094-28) | Limited Availability | 2026-09-22 |
Source facts
Grouped generic ingredient: Fentanyl Citrate Injection · 19 package records
Therapeutic categories: Analgesia/Addiction, Pediatric
Dosage forms: Injection
Routes: INTRAMUSCULAR, INTRAVENOUS
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.