Dexmedetomidine Hydrochloride Injection
Brand names: Dexmedetomidine, Dexmedetomidine Hydrochloride, Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride, Dexmedetomidine In Dextrose, Precedex
Category: Anesthesia
Unavailable 9Available 46Not specified 3
FDA status: Current, To Be Discontinued · Last FDA update: Sep 21, 2026 · First posted: Apr 10, 2020 (in shortage 6 years 5 months) · 17 manufacturers, 58 listed presentations
As of Sep 21, 2026, the FDA lists Dexmedetomidine Hydrochloride Injection as being discontinued. Of 58 manufacturer presentations, 9 Unavailable, 46 Available, 3 Not specified.
Ask your pharmacist: which of the 17 manufacturers below can they order right now, and whether a different strength or form of Dexmedetomidine Hydrochloride Injection is available. For alternatives, talk to your prescriber — see what to do if your medication is in shortage.
| Presentation & package NDC | Manufacturer | Availability | FDA note |
|---|---|---|---|
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20) NDC 63323-671-20 |
Fresenius Kabi USA, LLC | Unavailable | Expected recovery: TBD |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-50) NDC 63323-671-50 |
Fresenius Kabi USA, LLC | Unavailable | Estimated recovery: TBD |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00) NDC 63323-671-00 |
Fresenius Kabi USA, LLC | Unavailable | Expected recovery: TBD |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) NDC 42023-187-10 |
Par Health, USA LLC | Unavailable | Estimated recovery: TBD; Please check wholesalers for inventory |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) NDC 42023-186-20 |
Par Health, USA LLC | Unavailable | Estimated recovery: TBD; Please check wholesalers for inventory |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8) NDC 70121-1388-8 |
Amneal Pharmaceuticals | Available | Inventory available 4 to 5 month as per current demand. Next supply: week of 06/29/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7) NDC 70121-1389-7 |
Amneal Pharmaceuticals | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10) NDC 55150-297-10 |
Eugia US LLC | Available | Check wholesalers for inventory |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10) NDC 55150-296-10 |
Eugia US LLC | Available | Check wholesalers for inventory |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58) NDC 43598-976-58 |
Gland Pharma Limited | Available | Distributed by DRL |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58) NDC 43598-975-58 |
Gland Pharma Limited | Available | Distributed by DRL |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24) NDC 44567-602-24 |
HQ Specialty Pharma | Available | Marketed by WG Critical Care |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24) NDC 44567-603-24 |
HQ Specialty Pharma | Available | Marketed by WG Critical Care |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05) NDC 71225-126-05 |
Slayback Pharma | Not specified | Discontinuation of the manufacture of the drug |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06) NDC 71225-126-06 |
Slayback Pharma | Not specified | Discontinuation of the manufacture of the drug |
| Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) NDC 70121-1388-1 |
Amneal Pharmaceuticals | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95) NDC 0781-3493-95 |
Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Available | Marketed by Sandoz Inc.; Customer service: 800-525-8747 |
| Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) NDC 70121-1389-1 |
Amneal Pharmaceuticals | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93) NDC 16729-432-93 |
Accord Healthcare Inc. | Unavailable | Discontinuation of the manufacture of the drug |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02) NDC 63323-421-02 |
Fresenius Kabi USA, LLC | Unavailable | Estimated recovery: TBD |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25) NDC 0143-9532-25 |
Hikma Pharmaceuticals USA, Inc. | Unavailable | Product temporarily on backorder. Additional lots will be available in the September 2026 timeframe. |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02) NDC 55150-209-02 |
Eugia US LLC | Available | Check wholesalers for inventory |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04) NDC 44567-600-04 |
HQ Specialty Pharma | Available | Marketed by WG Critical Care |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04) NDC 44567-601-04 |
HQ Specialty Pharma | Available | Marketed by WG Critical Care |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03) NDC 71288-505-03 |
Meitheal Pharmaceuticals, Inc. | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) NDC 67457-251-02 |
Mylan Institutional, a Viatris Company | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) NDC 42023-146-25 |
Par Health, USA LLC | Available | Please check wholesalers for inventory |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-758-04) NDC 70069-758-04 |
Somerset Therapeutics, LLC | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04) NDC 70069-759-04 |
Somerset Therapeutics, LLC | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) NDC 16729-239-93 |
Accord Healthcare Inc. | Not specified | Discontinuation of the manufacture of the drug |
| Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02) NDC 83634-600-02 |
Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) | Available | Distributed by Avenacy; Contact information: 877-283-6229 |
| Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (NDC 0781-3494-95) NDC 0781-3494-95 |
Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Available | Marketed by Sandoz Inc.; Customer service: 800-525-8747 |
| Precedex, Injection, 200 mcg/50 mL (NDC 0409-7838-24) NDC 0409-7838-24 |
Pfizer Inc. | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42) NDC 66794-230-42 |
Gland Pharma Limited | Available | Marketed by Piramal Critical Care Inc.: 800-414-1901 |
| Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) NDC 0338-9555-24 |
Baxter Healthcare | Unavailable | Estimated recovery: September 2026 |
| Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) NDC 43066-555-24 |
Baxter Healthcare | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) NDC 67457-924-50 |
Mylan Institutional, a Viatris Company | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (NDC 0781-3495-95) NDC 0781-3495-95 |
Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Available | Marketed by Sandoz Inc.; Customer service: 800-525-8747 |
| Precedex, Injection, 400 mcg/100 mL (NDC 0409-7853-24) NDC 0409-7853-24 |
Pfizer Inc. | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) NDC 43066-557-12 |
Baxter Healthcare | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) NDC 0338-9557-12 |
Baxter Healthcare | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) NDC 67457-925-10 |
Mylan Institutional, a Viatris Company | Available | - |
| Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12) NDC 0409-7875-12 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01) NDC 0409-2815-01 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01) NDC 0409-1434-01 |
Pfizer Inc. | Available | - |
| Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10) NDC 52536-125-10 |
Azurity Pharmaceuticals, Inc | Available | Distributed by Wilshire Pharmaceuticals, Inc. |
| Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10) NDC 72572-127-10 |
Azurity Pharmaceuticals, Inc | Available | Distributed by Civica |
| Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08) NDC 52536-126-08 |
Azurity Pharmaceuticals, Inc | Available | Distributed by Wilshire Pharmaceuticals, Inc. |
| Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) NDC 72572-128-08 |
Azurity Pharmaceuticals, Inc | Available | Distributed by Civica |
| Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02) NDC 0409-1638-02 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20) NDC 0409-1454-20 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50) NDC 0409-1660-50 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20) NDC 0409-4596-20 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02) NDC 0409-0155-02 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10) NDC 0409-1174-10 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) NDC 0409-1596-10 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20) NDC 0409-1660-20 |
Pfizer Inc. | Available | - |
| Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10) NDC 0409-3301-10 |
Pfizer Inc. | Available | - |
Related medications in shortage
Other Anesthesia medications currently on the FDA shortage list — useful context if you and your prescriber are weighing alternatives. Always confirm with your pharmacist.
Change log
No changes recorded yet.
Tracking began Oct 1, 2026. We check the FDA every 6 hours; any real change - a manufacturer moving from Limited to Available, a new recovery date, a new listing - shows up here with its date.
Tracking began Oct 1, 2026. We check the FDA every 6 hours; any real change - a manufacturer moving from Limited to Available, a new recovery date, a new listing - shows up here with its date.
Cite this: “FDA drug-shortage status for Dexmedetomidine Hydrochloride Injection (FDA data as of Sep 21, 2026). Shortage Watch, openFDA.”
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FDA data last synced Oct 1, 2026 (FDA record dated Sep 30, 2026).