Dexmedetomidine Hydrochloride Injection shortage
Current 60 presentations · 17 manufacturers · first FDA posting 2020-04-10 · last update 2026-10-15
Manufacturers: Accord Healthcare Inc., Amneal Pharmaceuticals, Azurity Pharmaceuticals, Inc, Baxter Healthcare, Eugia US LLC, Fresenius Kabi USA, LLC, Gland Pharma Limited, HQ Specialty Pharma, Hikma Pharmaceuticals USA, Inc., Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.), Jiangsu Hengrui Pharmaceuticals Co., Ltd., Meitheal Pharmaceuticals, Inc., Mylan Institutional, a Viatris Company, Par Health, USA LLC, Pfizer Inc., Slayback Pharma, Somerset Therapeutics, LLC
Stated reasons (per FDA): Delay in shipping of the drug; Demand increase for the drug; Discontinuation of the manufacture of the drug; Other
Presentations
| Presentation | Manufacturer | Status | Reason | Notes (FDA) | Dates |
|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) | Accord Healthcare Inc. | Current Unavailable |
Discontinuation of the manufacture of the drug | Discontinuation of the manufacture of the drug | Posted 04/10/2020 Updated 09/15/2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93) | Accord Healthcare Inc. | Current Unavailable |
Discontinuation of the manufacture of the drug | Discontinuation of the manufacture of the drug | Posted 04/10/2020 Updated 09/15/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) | Amneal Pharmaceuticals | Current Available |
— | Posted 04/10/2020 Updated 10/05/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8) | Amneal Pharmaceuticals | Current Available |
— | Posted 04/10/2020 Updated 10/06/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) | Amneal Pharmaceuticals | Current Available |
— | Posted 04/10/2020 Updated 10/05/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7) | Amneal Pharmaceuticals | Current Available |
— | Posted 04/10/2020 Updated 10/06/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10) | Azurity Pharmaceuticals, Inc | Current Available |
— | Distributed by Wilshire Pharmaceuticals, Inc. | Posted 04/10/2020 Updated 09/16/2026 |
| Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08) | Azurity Pharmaceuticals, Inc | Current Available |
— | Distributed by Wilshire Pharmaceuticals, Inc. | Posted 04/10/2020 Updated 09/16/2026 |
| Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10) | Azurity Pharmaceuticals, Inc | Current Available |
— | Distributed by Civica | Posted 04/10/2020 Updated 09/16/2026 |
| Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) | Azurity Pharmaceuticals, Inc | Current Available |
— | Distributed by Civica | Posted 04/10/2020 Updated 09/16/2026 |
| Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) | Baxter Healthcare | Current Available |
— | Posted 04/10/2020 Updated 10/02/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) | Baxter Healthcare | Current Available |
— | Posted 04/10/2020 Updated 10/02/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) | Baxter Healthcare | Current Available |
— | Posted 04/10/2020 Updated 10/02/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) | Baxter Healthcare | Current Available |
— | Posted 04/10/2020 Updated 10/02/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02) | Eugia US LLC | Current Available |
— | Check wholesalers for inventory | Posted 04/10/2020 Updated 10/02/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10) | Eugia US LLC | Current Available |
— | Check wholesalers for inventory | Posted 04/10/2020 Updated 10/02/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10) | Eugia US LLC | Current Available |
— | Check wholesalers for inventory | Posted 04/10/2020 Updated 10/02/2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02) | Fresenius Kabi USA, LLC | Current Unavailable |
Demand increase for the drug | Estimated recovery: TBD | Posted 04/10/2020 Updated 10/15/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00) | Fresenius Kabi USA, LLC | Current Unavailable |
Delay in shipping of the drug | Expected recovery: TBD | Posted 04/10/2020 Updated 10/15/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20) | Fresenius Kabi USA, LLC | Current Unavailable |
Other | Expected recovery: TBD | Posted 04/10/2020 Updated 10/15/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-50) | Fresenius Kabi USA, LLC | Current Unavailable |
Delay in shipping of the drug | Estimated recovery: TBD | Posted 04/10/2020 Updated 10/15/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58) | Gland Pharma Limited | Current Available |
— | Distributed by DRL | Posted 04/10/2020 Updated 07/22/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58) | Gland Pharma Limited | Current Available |
— | Distributed by DRL | Posted 04/10/2020 Updated 07/22/2026 |
| Dexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42) | Gland Pharma Limited | Current Available |
— | Marketed by Piramal Critical Care Inc.: 800-414-1901 | Posted 04/10/2020 Updated 07/22/2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04) | HQ Specialty Pharma | Current Available |
— | Marketed by WG Critical Care | Posted 04/10/2020 Updated 10/01/2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04) | HQ Specialty Pharma | Current Available |
— | Marketed by WG Critical Care | Posted 04/10/2020 Updated 10/01/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24) | HQ Specialty Pharma | Current Available |
— | Marketed by WG Critical Care | Posted 04/10/2020 Updated 10/01/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24) | HQ Specialty Pharma | Current Available |
— | Marketed by WG Critical Care | Posted 04/10/2020 Updated 10/01/2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25) | Hikma Pharmaceuticals USA, Inc. | Current Unavailable |
Demand increase for the drug | Product temporarily on backorder. Additional lots will be available in the September 2026 timeframe. | Posted 04/10/2020 Updated 09/18/2026 |
| Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02) | Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) | Current Unavailable |
Discontinuation of the manufacture of the drug | Discontinuation of the manufacture of the drug; Distributed by Avenacy; Contact information: 877-283-6229 | Posted 04/10/2020 Updated 10/14/2026 |
| Dexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Current Available |
— | Marketed by Sandoz Inc.; Customer service: 800-525-8747 | Posted 04/10/2020 Updated 10/05/2026 |
| Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (NDC 0781-3494-95) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Current Available |
— | Marketed by Sandoz Inc.; Customer service: 800-525-8747 | Posted 04/10/2020 Updated 10/05/2026 |
| Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (NDC 0781-3495-95) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Current Available |
— | Marketed by Sandoz Inc.; Customer service: 800-525-8747 | Posted 04/10/2020 Updated 10/05/2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03) | Meitheal Pharmaceuticals, Inc. | Current Available |
— | Posted 04/10/2021 Updated 08/27/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) | Mylan Institutional, a Viatris Company | Current Available |
— | Posted 04/10/2020 Updated 10/05/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) | Mylan Institutional, a Viatris Company | Current Available |
— | Posted 04/10/2020 Updated 10/05/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) | Mylan Institutional, a Viatris Company | Current Available |
— | Posted 04/10/2020 Updated 10/05/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) | Par Health, USA LLC | Current Unavailable |
Other | Please check wholesalers for inventory | Posted 04/10/2020 Updated 10/15/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) | Par Health, USA LLC | Current Unavailable |
Other | Estimated recovery: TBD; Please check wholesalers for inventory | Posted 04/10/2020 Updated 10/15/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) | Par Health, USA LLC | Current Unavailable |
Other | Estimated recovery: TBD; Please check wholesalers for inventory | Posted 04/10/2020 Updated 10/15/2026 |
| Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 08/24/2026 | |
| Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/08/2026 | |
| Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/08/2026 | |
| Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 200 mcg/50 mL (NDC 0409-7838-24) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 400 mcg/100 mL (NDC 0409-7853-24) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12) | Pfizer Inc. | Current Available |
— | Posted 04/10/2020 Updated 09/21/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-758-04) | Somerset Therapeutics, LLC | Current Available |
— | Posted 04/10/2020 Updated 09/11/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04) | Somerset Therapeutics, LLC | Current Available |
— | Posted 04/10/2020 Updated 09/11/2026 | |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) | Accord Healthcare Inc. | To Be Discontinued | — | Discontinuation of the manufacture of the drug | Posted 04/21/2026 Updated 04/21/2026 Discontinued 04/21/2026 |
| Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02) | Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) | To Be Discontinued | — | Discontinuation of the manufacture of the drug; Distributed by Avenacy; Contact information: 877-283-6229 | Posted 10/14/2026 Updated 10/14/2026 Discontinued 10/14/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05) | Slayback Pharma | To Be Discontinued | — | Discontinuation of the manufacture of the drug | Posted 06/05/2026 Updated 06/05/2026 Discontinued 06/05/2026 |
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06) | Slayback Pharma | To Be Discontinued | — | Discontinuation of the manufacture of the drug | Posted 06/05/2026 Updated 06/05/2026 Discontinued 06/05/2026 |
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