6/2/2025

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, 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, Amneal, 4 mcg/mL, 50 mL premixed bag, 24 count, NDC 70121-1711-09
- Dexmedetomidine hydrochloride solution for injection, Baxter, 4 mcg/mL, 50 mL premixed bag, 24 count, NDC 00338-9555-24
- 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, Hikma, 4 mcg/mL, 100 mL premixed bag, 10 count, NDC 00143-9525-10

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 information is forthcoming.
- 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, 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, Baxter, 4 mcg/mL, 100 mL premixed bag, 12 count, NDC 00338-9557-12
- 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, 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, 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, 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 glass bottles available with short expiration dating (July 2025). The 100 mL glass bottles are on allocation. The 50 mL and 100 mL premixed bags are on back order with an estimated release date in 2nd quarter 2025.
- Baxter has dexmedetomidine 4 mcg/mL 50 mL premixed bags in limited supply.
- Eugia has dexmedetomidine 4 mcg/mL 100 mL premixed bags on back order and the company cannot estimate a release date.
- Hikma has dexmedetomidine 4 mcg/mL 100 mL premixed bags on allocation.
- Pfizer has Precedex 4 mcg/mL 250 mL glass bottles in limited supply and the company is releasing supplies weekly.

Updated

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