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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Dexmedetomidine Hydrochloride Injection
Status: Currently in Shortage
»Date first posted: 04/10/2020
»Therapeutic Categories: Anesthesia

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Accord Healthcare Inc. (Revised 07/23/2024)

Company Contact Information:
866-941-7875, option 2

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, 100 ug/1 mL (NDC 16729-239-93) Unavailable Resupply TBD Requirements related to complying with good manufacturing practices
Injection, 100 ug/1 mL (NDC 16729-432-93) Unavailable Discontinuation of the manufacture of the drug Discontinuation of the manufacture of the drug

Amneal Pharmaceuticals (Reverified 07/11/2024)

Company Contact Information:
877-835-5472

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) Available
Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) Available
Injection, 4 ug/1 mL (NDC 70121-1388-8) Available
Injection, 4 ug/1 mL (NDC 70121-1389-7) Available

Baxter Healthcare (Reverified 07/17/2024)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) Available
Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) Available
Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) Available
Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) Available

Eugia US LLC (Reverified 07/17/2024)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02) Unavailable On backorder. Recovery: TBD. Check wholesalers for inventory Demand increase for the drug
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10) Available Check wholesalers for inventory
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10) Available Check wholesalers for inventory

Fresenius Kabi USA, LLC (Revised 06/27/2024)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, 4 ug/1 mL (NDC 63323-671-20) Unavailable Next release not available at this time. Demand increase for the drug
Injection, 4 ug/1 mL (NDC 63323-671-50) Unavailable Not available at this time. Demand increase for the drug
Injection, 4 ug/1 mL (NDC 63323-671-00) Unavailable Not available at this time. Demand increase for the drug
Injection, 100 ug/1 mL (NDC 63323-421-02) Available Check wholesalers for inventory

Gland Pharma Limited (Revised 07/15/2024)

Company Contact Information:
866-733-3952

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58) Available
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58) Available
Injection, 200 ug/2 mL (NDC 66794-230-42) Available Marketed by Piramal Critical Care Inc.: 800-414-1901

Hikma Pharmaceuticals USA, Inc. (Reverified 07/01/2024)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25) Available

HQ Specialty Pharma (Reverified 05/18/2024)

Company Contact Information:
WG Critical Care 888-493-0861

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, 100 ug/1 mL (NDC 44567-600-04) Available Marketed by WG Critical Care
Injection, 100 ug/1 mL (NDC 44567-601-04) Available Marketed by WG Critical Care
Injection, 4 ug/1 mL (NDC 44567-602-24) Available Marketed by WG Critical Care
Injection, 4 ug/1 mL (NDC 44567-603-24) Available Marketed by WG Critical Care

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Revised 07/11/2024)

Company Contact Information:
See Related Information section below for customer service information

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, 80 mcg/20 mL (NDC 0781-3493-95) Available Marketed by Sandoz Inc.; Customer service: 800-525-8747
Injection, 200 mcg/50 mL (NDC 0781-3494-95) Available Marketed by Sandoz Inc.; Customer service: 800-525-8747
Injection, 400 mcg/100 mL (NDC 0781-3495-95) Available Marketed by Sandoz Inc.; Customer service: 800-525-8747

Meitheal Pharmaceuticals, Inc. (Revised 07/03/2024)

Company Contact Information:
844-824-8426

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03) Available Estimated recovery end of August 2024 Demand increase for the drug

Mylan Institutional, a Viatris Company (Reverified 07/18/2024)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) Available
Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) Available
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) Available

Par Pharmaceutical, Inc. (Reverified 07/15/2024)

Company Contact Information:
800-828-9393

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, 100 ug/1 mL (NDC 42023-146-25) Available Please check wholesalers for inventory
Injection, 4 ug/1 mL (NDC 42023-186-20) Limited Availability Please check wholesalers for inventory Other
Injection, 4 ug/1 mL (NDC 42023-187-10) Limited Availability Please check wholesalers for inventory Other

Pfizer Inc. (Revised 07/15/2024)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10) Available
Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20) Available
Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02) Available
Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10) Available
Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01) Available
Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01) Available
Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20) Available
Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20) Limited Availability Limited Supply Available. Next Delivery: August 2024; Estimated Recovery: June 2025 Demand increase for the drug
Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50) Available
Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) Available
Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02) Available

Slayback Pharma (Revised 01/15/2024)

Company Contact Information:
844-566-2505

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05) Available
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06) Available
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