# Dexmedetomidine Hydrochloride Injection: FDA shortage status > FDA source status only. Nationwide status is not local pharmacy inventory. This page does not provide medical, treatment, substitution, or dosing advice. - Derived status: current - Source statuses: Current, To Be Discontinued - FDA package records: 59 - Latest FDA row update: 08/20/2026 - Retrieved: 2026-08-22T15:54:11+00:00 ## FDA package and manufacturer records - Accord Healthcare Inc. — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) — FDA availability: Not stated — updated: 04/21/2026 - Accord Healthcare Inc. — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) — FDA availability: Unavailable — updated: 08/17/2026 - Accord Healthcare Inc. — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93) — FDA availability: Unavailable — updated: 08/17/2026 - Amneal Pharmaceuticals — Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) — FDA availability: Available — updated: 06/17/2026 - Amneal Pharmaceuticals — Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) — FDA availability: Available — updated: 06/17/2026 - Amneal Pharmaceuticals — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8) — FDA availability: Available — updated: 06/17/2026 - Amneal Pharmaceuticals — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7) — FDA availability: Available — updated: 06/17/2026 - Azurity Pharmaceuticals, Inc — Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10) — FDA availability: Available — updated: 08/17/2026 - Azurity Pharmaceuticals, Inc — Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10) — FDA availability: Available — updated: 08/17/2026 - Azurity Pharmaceuticals, Inc — Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08) — FDA availability: Available — updated: 08/17/2026 - Azurity Pharmaceuticals, Inc — Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) — FDA availability: Available — updated: 08/17/2026 - Baxter Healthcare — Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) — FDA availability: Unavailable — updated: 08/17/2026 - Baxter Healthcare — Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) — FDA availability: Available — updated: 08/17/2026 - Baxter Healthcare — Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) — FDA availability: Available — updated: 08/17/2026 - Baxter Healthcare — Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) — FDA availability: Available — updated: 08/17/2026 - Eugia US LLC — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02) — FDA availability: Available — updated: 08/06/2026 - Eugia US LLC — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10) — FDA availability: Available — updated: 08/06/2026 - Eugia US LLC — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10) — FDA availability: Available — updated: 08/06/2026 - Fresenius Kabi USA, LLC — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02) — FDA availability: Unavailable — updated: 08/04/2026 - Fresenius Kabi USA, LLC — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00) — FDA availability: Unavailable — updated: 08/04/2026 - Fresenius Kabi USA, LLC — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20) — FDA availability: Unavailable — updated: 08/04/2026 - Fresenius Kabi USA, LLC — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-50) — FDA availability: Unavailable — updated: 08/04/2026 - Gland Pharma Limited — Dexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42) — FDA availability: Available — updated: 07/22/2026 - Gland Pharma Limited — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58) — FDA availability: Available — updated: 07/22/2026 - Gland Pharma Limited — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58) — FDA availability: Available — updated: 07/22/2026 - HQ Specialty Pharma — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04) — FDA availability: Available — updated: 08/17/2026 - HQ Specialty Pharma — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04) — FDA availability: Available — updated: 08/17/2026 - HQ Specialty Pharma — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24) — FDA availability: Available — updated: 08/17/2026 - HQ Specialty Pharma — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24) — FDA availability: Available — updated: 08/17/2026 - Hikma Pharmaceuticals USA, Inc. — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25) — FDA availability: Unavailable — updated: 08/13/2026 - Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) — Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02) — FDA availability: Available — updated: 07/30/2026 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. — Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (NDC 0781-3494-95) — FDA availability: Available — updated: 07/30/2026 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. — Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (NDC 0781-3495-95) — FDA availability: Available — updated: 07/30/2026 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. — Dexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95) — FDA availability: Available — updated: 07/30/2026 - Meitheal Pharmaceuticals, Inc. — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03) — FDA availability: Available — updated: 06/01/2026 - Mylan Institutional, a Viatris Company — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) — FDA availability: Available — updated: 08/20/2026 - Mylan Institutional, a Viatris Company — Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) — FDA availability: Available — updated: 08/20/2026 - Mylan Institutional, a Viatris Company — Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) — FDA availability: Available — updated: 08/20/2026 - Par Health, USA LLC — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) — FDA availability: Available — updated: 08/18/2026 - Par Health, USA LLC — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) — FDA availability: Unavailable — updated: 08/18/2026 - Par Health, USA LLC — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) — FDA availability: Unavailable — updated: 08/18/2026 - Pfizer Inc. — Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 200 mcg/50 mL (NDC 0409-7838-24) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 400 mcg/100 mL (NDC 0409-7853-24) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20) — FDA availability: Available — updated: 08/07/2026 - Pfizer Inc. — Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10) — FDA availability: Available — updated: 08/07/2026 - Slayback Pharma — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05) — FDA availability: Not stated — updated: 06/05/2026 - Slayback Pharma — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06) — FDA availability: Not stated — updated: 06/05/2026 - Somerset Therapeutics, LLC — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-758-04) — FDA availability: Available — updated: 07/20/2026 - Somerset Therapeutics, LLC — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04) — FDA availability: Available — updated: 07/20/2026 ## Sources and formats - [FDA openFDA source](https://api.fda.gov/drug/shortages.json) - [Canonical HTML](https://citefacts.com/shortages/dexmedetomidine-hydrochloride-injection) - [JSON record](https://citefacts.com/shortages/dexmedetomidine-hydrochloride-injection.json)