● ANSWER
Sourced & dated

Dexmedetomidine FDA Drug Shortage Status

FDA lists human-labeled dexmedetomidine injection in shortage, while Dexdomitor provides 0.1 mg/mL and 0.5 mg/mL veterinary formulations.

● WHAT'S DOCUMENTED

FDA lists human-labeled dexmedetomidine hydrochloride injection in shortage with variable availability across NDCs, while veterinary Dexdomitor is approved under NADA 141-267.

Dexmedetomidine: human-labeled FDA records matched to our veterinary drug catalog.

Dexmedetomidine FDA product records

FDA fieldProduct-specific value
Record 1Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-1596-10
Record 2Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1)
CompanyAmneal Pharmaceuticals
First posted04/10/2020
FDA updated10/05/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC70121-1388-1
Record 3Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24)
CompanyHQ Specialty Pharma
First posted04/10/2020
FDA updated11/02/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationMarketed by WG Critical Care
Package NDC44567-602-24
Record 4Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93)
CompanyAccord Healthcare Inc.
First posted04/10/2020
FDA updated09/15/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationDiscontinuation of the manufacture of the drug
Package NDC16729-432-93
Record 5Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (NDC 0781-3494-95)
CompanyJiangsu Hengrui Pharmaceuticals Co., Ltd.
First posted04/10/2020
FDA updated10/05/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationMarketed by Sandoz Inc.; Customer service: 800-525-8747
Package NDC0781-3494-95
Record 6Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24)
CompanyHQ Specialty Pharma
First posted04/10/2020
FDA updated11/02/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationMarketed by WG Critical Care
Package NDC44567-603-24
Record 7Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95)
CompanyJiangsu Hengrui Pharmaceuticals Co., Ltd.
First posted04/10/2020
FDA updated10/05/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationMarketed by Sandoz Inc.; Customer service: 800-525-8747
Package NDC0781-3493-95
Record 8Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1)
CompanyAmneal Pharmaceuticals
First posted04/10/2020
FDA updated10/05/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC70121-1389-1
Record 9Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93)
CompanyAccord Healthcare Inc.
First posted04/10/2020
FDA updated09/15/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationDiscontinuation of the manufacture of the drug
Package NDC16729-239-93
Record 10Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-0155-02
Record 11Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25)
CompanyHikma Pharmaceuticals USA, Inc.
First posted04/10/2020
FDA updated10/14/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationAdditional product will be made available as it is released.
Package NDC0143-9532-25
Record 12Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-2815-01
Record 13Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02)
CompanyMylan Institutional, a Viatris Company
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC67457-251-02
Record 14Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58)
CompanyGland Pharma Limited
First posted04/10/2020
FDA updated10/21/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationDistributed by DRL
Package NDC43598-975-58
Record 15Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-50)
CompanyFresenius Kabi USA, LLC
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationEstimated recovery: TBD
Package NDC63323-671-50
Record 16Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04)
CompanyHQ Specialty Pharma
First posted04/10/2020
FDA updated11/02/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationMarketed by WG Critical Care
Package NDC44567-601-04
Record 17Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10)
CompanyPar Health, USA LLC
First posted04/10/2020
FDA updated11/02/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationEstimated recovery: TBD; Please check wholesalers for inventory
Package NDC42023-187-10
Record 18Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02)
CompanyEugia US LLC
First posted04/10/2020
FDA updated10/19/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationCheck wholesalers for inventory
Package NDC55150-209-02
Record 19Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7)
CompanyAmneal Pharmaceuticals
First posted04/10/2020
FDA updated10/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC70121-1389-7
Record 20Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24)
CompanyBaxter Healthcare
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC43066-555-24
Record 21Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25)
CompanyPar Health, USA LLC
First posted04/10/2020
FDA updated11/02/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationPlease check wholesalers for inventory
Package NDC42023-146-25
Record 22Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58)
CompanyGland Pharma Limited
First posted04/10/2020
FDA updated10/21/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationDistributed by DRL
Package NDC43598-976-58
Record 23Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24)
CompanyBaxter Healthcare
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0338-9555-24
Record 24Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10)
CompanyAzurity Pharmaceuticals, Inc
First posted04/10/2020
FDA updated10/15/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationDistributed by Civica
Package NDC72572-127-10
Record 25Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03)
CompanyMeitheal Pharmaceuticals, Inc.
First posted04/10/2021
FDA updated08/27/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC71288-505-03
Record 26Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10)
CompanyMylan Institutional, a Viatris Company
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC67457-925-10
Record 27Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-1454-20
Record 28Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42)
CompanyGland Pharma Limited
First posted04/10/2020
FDA updated10/21/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationMarketed by Piramal Critical Care Inc.: 800-414-1901
Package NDC66794-230-42
Record 29Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-1174-10
Record 30Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 400 mcg/100 mL (NDC 0409-7853-24)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-7853-24
Record 31Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50)
CompanyMylan Institutional, a Viatris Company
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC67457-924-50
Record 32Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 200 mcg/50 mL (NDC 0409-7838-24)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-7838-24
Record 33Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12)
CompanyBaxter Healthcare
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC43066-557-12
Record 34Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-7875-12
Record 35Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8)
CompanyAmneal Pharmaceuticals
First posted04/10/2020
FDA updated10/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC70121-1388-8
Record 36Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04)
CompanyHQ Specialty Pharma
First posted04/10/2020
FDA updated11/02/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationMarketed by WG Critical Care
Package NDC44567-600-04
Record 37Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-758-04)
CompanySomerset Therapeutics, LLC
First posted04/10/2020
FDA updated10/27/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC70069-758-04
Record 38Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12)
CompanyBaxter Healthcare
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0338-9557-12
Record 39Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08)
CompanyAzurity Pharmaceuticals, Inc
First posted04/10/2020
FDA updated10/15/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationDistributed by Wilshire Pharmaceuticals, Inc.
Package NDC52536-126-08
Record 40Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-3301-10
Record 41Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-4596-20
Record 42Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-1434-01
Record 43Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02)
CompanyFresenius Kabi USA, LLC
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationEstimated recovery: TBD
Package NDC63323-421-02
Record 44Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10)
CompanyAzurity Pharmaceuticals, Inc
First posted04/10/2020
FDA updated10/15/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationDistributed by Wilshire Pharmaceuticals, Inc.
Package NDC52536-125-10
Record 45Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20)
CompanyPar Health, USA LLC
First posted04/10/2020
FDA updated11/02/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationEstimated recovery: TBD; Please check wholesalers for inventory
Package NDC42023-186-20
Record 46Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04)
CompanySomerset Therapeutics, LLC
First posted04/10/2020
FDA updated10/27/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC70069-759-04
Record 47Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00)
CompanyFresenius Kabi USA, LLC
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationExpected recovery: TBD
Package NDC63323-671-00
Record 48Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-1660-50
Record 49Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (NDC 0781-3495-95)
CompanyJiangsu Hengrui Pharmaceuticals Co., Ltd.
First posted04/10/2020
FDA updated10/05/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationMarketed by Sandoz Inc.; Customer service: 800-525-8747
Package NDC0781-3495-95
Record 50Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-1638-02
Record 51Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20)
CompanyFresenius Kabi USA, LLC
First posted04/10/2020
FDA updated11/03/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationExpected recovery: TBD
Package NDC63323-671-20
Record 52Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10)
CompanyEugia US LLC
First posted04/10/2020
FDA updated10/19/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationCheck wholesalers for inventory
Package NDC55150-296-10
Record 53Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08)
CompanyAzurity Pharmaceuticals, Inc
First posted04/10/2020
FDA updated10/15/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationDistributed by Civica
Package NDC72572-128-08
Record 54Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02)
CompanyJiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.)
First posted04/10/2020
FDA updated10/14/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityUnavailable
FDA additional informationDiscontinuation of the manufacture of the drug; Distributed by Avenacy; Contact information: 877-283-6229
Package NDC83634-600-02
Record 55Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationPrecedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20)
CompanyPfizer Inc.
First posted04/10/2020
FDA updated11/06/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationNot stated
Package NDC0409-1660-20
Record 56Dexmedetomidine Hydrochloride Injection
FDA generic nameDexmedetomidine Hydrochloride Injection
FDA shortage statusCurrent
Dosage formInjection
PresentationDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10)
CompanyEugia US LLC
First posted04/10/2020
FDA updated10/19/2026
Resolved dateNot stated
Discontinued dateNot stated
Human therapeutic categoryAnesthesia
Presentation availabilityAvailable
FDA additional informationCheck wholesalers for inventory
Package NDC55150-297-10

Dexmedetomidine: practical discussion

FDA shortage board

Human Drug Shortage Status and Record Interpretation

FDA lists human-labeled dexmedetomidine in shortage as of 2026-11-07.

Veterinary Approvals and Supply Data Scope

Dexmedetomidine is approved for veterinary use under NADA 141-267 as Dexdomitor (Zoetis Inc.) in 0.1 mg/mL (15 mL multidose vial) and 0.5 mg/mL (10 mL multidose vial) sterile injectable solutions for dogs and cats. Information regarding animal drug shortages is maintained separately by the FDA Center for Veterinary Medicine.

Vetinuity

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● SOURCES
  1. 1. FDA CDER human drug shortage records. FDA shortage data. Checked 2026-11-13.
  2. 2. FDA CVM current and resolved animal drug shortages. FDA shortage data. Checked 2026-11-13.
  3. 3. FDA CVM shortage information. FDA shortage data. Checked 2026-11-13.
  4. 4. Dexdomitor US prescribing label. US prescribing information. Checked 2026-11-07.
● RELATED ANSWERS
● FAQ

Is dexmedetomidine injection currently listed in shortage by the FDA?

Yes, FDA lists human-labeled dexmedetomidine hydrochloride injection in shortage. Stock status varies by NDC and manufacturer, with specific presentations remaining Available while others are Unavailable or discontinued.

What availability does one FDA dexmedetomidine presentation record report?

In the saved FDA dexmedetomidine records, Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) from Pfizer Inc. has availability listed as Available. This describes that presentation in the checked snapshot.

Is dexmedetomidine listed on the FDA CVM animal drug shortage table?

As of 2026-11-07, dexmedetomidine is absent from the FDA CVM animal drug shortage table. This does not establish product availability.

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