8/12/2025

Dexmedetomidine Hydrochloride 4 mcg/mL Premix for Injection

Products Affected - Description

- Precedex solution for injection, Pfizer, 4 mcg/mL, 250 mL glass bottle, 1 count, NDC 00409-1434-01
- Dexmedetomidine hydrochloride solution for injection, Amneal, 4 mcg/mL, 50 mL premixed bag, 24 count, NDC 70121-1711-09
- Dexmedetomidine hydrochloride solution for injection, Azurity, 4 mcg/mL, 100 mL plastic bottle, 24 count, NDC 71225-0133-02
- Dexmedetomidine hydrochloride solution for injection, Azurity, 4 mcg/mL, 50 mL plastic bottle, 24 count, NDC 71225-0132-02
- Dexmedetomidine hydrochloride solution for injection, Piramal Critical Care, 4 mcg/mL, 100 mL premixed vial, 24 count, NDC 66794-0235-41

Reason for the Shortage

- Amneal did not provide a reason for the shortage.
- Azurity has dexmedetomidine premixes available.
- Baxter did not provide a reason for the shortage.
- Dr. Reddy's has dexmedetomidine premixes available.
- Eugia did not provide a reason for the shortage.
- Fresenius Kabi has dexmedetomidine premixes available.
- Hikma did not provide a reason for the shortage.
- Pfizer has Precedex 250 mL glass bottles on shortage due to manufacturing delays.
- Piramal Critical Care did not provide a reason for the shortage.
- Sagent has dexmedetomidine premixes available.
- WG Critical Care has dexmedetomidine premixes available.

Available Products

- Precedex solution for injection, Pfizer, 4 mcg/mL, 100 mL glass bottle, 10 count, NDC 00409-1596-10
- Precedex solution for injection, Pfizer, 4 mcg/mL, 20 mL glass vial, 10 count, NDC 00409-1660-20
- Precedex solution for injection, Pfizer, 4 mcg/mL, 50 mL glass bottle, 20 count, NDC 00409-1660-50
- Dexmedetomidine hydrochloride solution for injection, Amneal, 4 mcg/mL, 100 mL glass bottle, 10 count, NDC 70121-1389-07
- Dexmedetomidine hydrochloride solution for injection, Amneal, 4 mcg/mL, 100 mL premixed bag, 24 count, NDC 70121-1712-02
- Dexmedetomidine hydrochloride solution for injection, Amneal, 4 mcg/mL, 50 mL glass bottle, 20 count, NDC 70121-1388-08
- Dexmedetomidine hydrochloride solution for injection, Baxter, 4 mcg/mL, 100 mL premixed bag, 12 count, NDC 00338-9557-12
- Dexmedetomidine hydrochloride solution for injection, Baxter, 4 mcg/mL, 50 mL premixed bag, 24 count, NDC 00338-9555-24
- Dexmedetomidine hydrochloride solution for injection, Dr. Reddy's, 4 mcg/mL, 100 mL glass bottle, 10 count, NDC 43598-0976-58
- Dexmedetomidine hydrochloride solution for injection, Dr. Reddy's, 4 mcg/mL, 50 mL glass bottle, 10 count, NDC 43598-0975-58
- Dexmedetomidine hydrochloride solution for injection, Eugia US, 4 mcg/mL, 100 mL glass bottle, 10 count, NDC 55150-0297-10
- Dexmedetomidine hydrochloride solution for injection, Eugia US, 4 mcg/mL, 50 mL glass bottle, 10 count, NDC 55150-0296-10
- Dexmedetomidine hydrochloride solution for injection, Fresenius Kabi, 4 mcg/mL, 100 mL glass bottle, 10 count, NDC 63323-0671-00
- Dexmedetomidine hydrochloride solution for injection, Fresenius Kabi, 4 mcg/mL, 20 mL vial, 10 count, NDC 63323-0671-20
- Dexmedetomidine hydrochloride solution for injection, Fresenius Kabi, 4 mcg/mL, 50 mL glass bottle, 25 count, NDC 63323-0671-50
- Dexmedetomidine hydrochloride solution for injection, Hikma, 4 mcg/mL, 100 mL premixed bag, 10 count, NDC 00143-9525-10
- Dexmedetomidine hydrochloride solution for injection, Hikma, 4 mcg/mL, 50 mL premixed bag, 10 count, NDC 00143-9526-10
- Dexmedetomidine hydrochloride solution for injection, Sagent, 4 mcg/mL, 100 mL glass bottle, 10 count, NDC 25021-0615-51
- Dexmedetomidine hydrochloride solution for injection, Sagent, 4 mcg/mL, 50 mL glass bottle, 10 count, NDC 25021-0615-50
- Dexmedetomidine hydrochloride solution for injection, Piramal Critical Care, 4 mcg/mL, 50 mL premixed vial, 24 count, NDC 66794-0234-44
- Dexmedetomidine hydrochloride solution for injection, WG Critical Care, 4 mcg/mL, 100 mL premixed bag, 24 count, NDC 44567-0603-24
- Dexmedetomidine hydrochloride solution for injection, WG Critical Care, 4 mcg/mL, 50 mL premixed bag, 24 count, NDC 44567-0602-24

Estimated Resupply Dates

- Amneal has dexmedetomidine 4 mcg/mL 50 mL premixed bags on back order and the company cannot estimate a release date.
- Azurity has dexmedetomidine 4 mcg/mL 50 mL and 100 mL bottles on back order and the company cannot estimate a release date.
- Piramal Critical Care has dexmedetomidine 4 mcg/mL 100 mL premixed vials available for contracted customers.
- Pfizer has Precedex 4 mcg/mL 250 mL glass bottles on back order and the company estimates a release date in October 2025.

Updated

Updated August 12, 2025 by Leslie Jensen, PharmD, Drug Information Specialist. Created June 2, 2025 by Leslie Jensen, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

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