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FDA shortage status: Remifentanil Hydrochloride Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2022-06-28. Latest FDA row update: 2026-10-05.
FDA lists 9 package records, with companies: Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., Mylan Institutional LLC, Mylan Institutional, a Viatris Company. Package NDCs: 0143-9391-10, 0143-9392-10, 0143-9393-10, 63323-723-03, 63323-724-05, 63323-725-10, 72078-034-01, 72078-035-02, 72078-036-05.
FDA shortage reason: Delay in shipping of the drug; Demand increase for the drug
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 | 63323-723-03 | Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-723-03) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-724-05 | Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-724-05) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-725-10 | Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-725-10) | Available | 2026-09-15 |
| Hikma Pharmaceuticals USA, Inc. | 0143-9391-10 | Remifentanil Hydrochloride, Injection, 1 mg per vial (NDC 0143-9391-10) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0143-9392-10 | Remifentanil Hydrochloride, Injection, 2 mg per vial (NDC 0143-9392-10) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0143-9393-10 | Remifentanil Hydrochloride, Injection, 5 mg per vial (NDC 0143-9393-10) | Available | 2026-09-18 |
| Mylan Institutional, a Viatris Company | 72078-034-01 | Ultiva, Injection, 1 mg/1 mL (NDC 72078-034-01) | Available | 2026-10-05 |
| Mylan Institutional, a Viatris Company | 72078-035-02 | Ultiva, Injection, 2 mg (NDC 72078-035-02) | Available | 2026-10-05 |
| Mylan Institutional, a Viatris Company | 72078-036-05 | Ultiva, Injection, 5 mg (NDC 72078-036-05) | Available | 2026-10-05 |
Source facts
Grouped generic ingredient: Remifentanil Hydrochloride Injection · 9 package records
Therapeutic categories: Analgesia/Addiction
Dosage forms: Injection
Routes: 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.