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Dexmedetomidine Hydrochloride Injection shortage

Dexmedetomidine Hydrochloride Injection is currently listed in shortage by the FDA. The FDA lists 59 affected products. The reported reason: Other; Delay in shipping of the drug; Discontinuation of the manufacture of the drug. This page was last refreshed from FDA data on Sep 22, 2026.

Current ⚠ Supply risk: Low Anesthesia 59 products 17 manufacturers 2,357 days · 6.5 yr First posted Apr 10, 2020 Updated Sep 17, 2026
Here’s the bottom line

Some makers of dexmedetomidine hydrochloride injection have reported a shortage lasting over a year. The same medicine — including Precedex — is still listed as available from other manufacturers not reporting a shortage.

Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
59
Affected NDCs
17
Reporting manufacturers
13/17
Reporting mfrs supplying
20/20
Affected strengths / sizes supplied
18%
NDCs unavailable
2,357
Days in shortage
26,759
Medicaid Rx (2025)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Sep 22, 2026 · yesterday

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Dexmedetomidine Hydrochloride Injection. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
59 NDCs
Available 46 Unavailable 10 To be discontinued 3
Affected strengths / sizes still supplied
Among manufacturers reporting this shortage
20/20 strengths / sizes
Sourceable 20
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
13/17 makers
With supply 13 No supply 4
✓ Other manufacturers not reporting a shortage
Still-marketed Dexmedetomidine Hydrochloride Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Hikma Pharmaceuticals USA Inc. Hospira, Inc. Sagent Pharmaceuticals Baxter Healthcare Company Sun Pharmaceuticals Industries, Inc. Piramal Critical Care Inc Precision Dose, Inc. Amneal Pharmaceuticals LLC
Plus 2 alternative dosage forms of Dexmedetomidine Hydrochloride.
See all other options & details →
Shortage timeline
  1. Sep 17, 2026
    Currently in shortage
    59 of 59 products affected.
  2. Sep 16, 2026
    FDA refreshed this shortage record
    4 products updated.
  3. Sep 15, 2026
    FDA refreshed this shortage record
    9 products updated.
  4. Sep 11, 2026
    FDA refreshed this shortage record
    2 products updated.
  5. Sep 8, 2026
    FDA refreshed this shortage record
    13 products updated.
  6. Aug 27, 2026
    FDA refreshed this shortage record
    1 product updated.
  7. Aug 24, 2026
    FDA refreshed this shortage record
    2 products updated.
  8. Aug 18, 2026
    FDA refreshed this shortage record
    1 product updated.
  9. Aug 17, 2026
    FDA refreshed this shortage record
    5 products updated.
  10. Aug 13, 2026
    FDA refreshed this shortage record
    1 product updated.
  11. Jul 22, 2026
    FDA refreshed this shortage record
    3 products updated.
  12. Jun 17, 2026
    FDA refreshed this shortage record
    4 products updated.
  13. Jun 5, 2026
    FDA refreshed this shortage record
    2 products updated.
  14. Jun 5, 2026
    More presentations reported
    2 more products added to the shortage.
  15. Apr 21, 2026
    FDA refreshed this shortage record
    1 product updated.
  16. Apr 21, 2026
    More presentations reported
    1 more product added to the shortage.
  17. Apr 10, 2021
    More presentations reported
    1 more product added to the shortage.
  18. Apr 10, 2020
    First reported to the FDA
    55 products first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Accord Healthcare Inc. 📞 866-941-7875, option 2 3 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) NDC 16729-0239-93 Unavailable Discontinuation of the manufacture of the drug Discontinuation of the manufacture of the drug
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93) NDC 16729-0432-93 Unavailable Discontinuation of the manufacture of the drug Discontinuation of the manufacture of the drug
To Be Discontinued Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) NDC 16729-0239-93 Discontinuation of the manufacture of the drug
Manufacturer: Amneal Pharmaceuticals 📞 866-525-7270 4 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) NDC 70121-1389-01 Available
Current Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) NDC 70121-1388-01 Available
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8) NDC 70121-1388-08 Available Inventory available 4 to 5 month as per current demand. Next supply: week of 06/29/2026
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7) NDC 70121-1389-07 Available
Manufacturer: Azurity Pharmaceuticals, Inc 📞 877-495-6856 4 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08) NDC 52536-0126-08 Available Distributed by Wilshire Pharmaceuticals, Inc.
Current Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10) NDC 72572-0127-10 Available Distributed by Civica
Current Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10) NDC 52536-0125-10 Available Distributed by Wilshire Pharmaceuticals, Inc.
Current Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) NDC 72572-0128-08 Available Distributed by Civica
Manufacturer: Baxter Healthcare 📞 888-229-0001 4 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) NDC 43066-0555-24 Available
Current Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) NDC 00338-9557-12 Available
Current Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) NDC 43066-0557-12 Available
Current Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) NDC 00338-9555-24 Unavailable Estimated recovery: September 2026 Other
Manufacturer: Eugia US LLC 📞 888-238-7880 3 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10) NDC 55150-0296-10 Available Check wholesalers for inventory
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02) NDC 55150-0209-02 Available Check wholesalers for inventory
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10) NDC 55150-0297-10 Available Check wholesalers for inventory
Manufacturer: Fresenius Kabi USA, LLC 📞 888-386-1300 4 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00) NDC 63323-0671-00 Unavailable Expected recovery: TBD Delay in shipping of the drug
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20) NDC 63323-0671-20 Unavailable Expected recovery: TBD Other
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02) NDC 63323-0421-02 Unavailable Estimated recovery: TBD Demand increase for the drug
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-50) NDC 63323-0671-50 Unavailable Estimated recovery: TBD Delay in shipping of the drug
Manufacturer: Gland Pharma Limited 📞 Distributed by DRL 3 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58) NDC 43598-0975-58 Available Distributed by DRL
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58) NDC 43598-0976-58 Available Distributed by DRL
Current Dexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42) NDC 66794-0230-42 Available Marketed by Piramal Critical Care Inc.: 800-414-1901
Manufacturer: HQ Specialty Pharma 📞 WG Critical Care 888-493-0861 4 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04) NDC 44567-0600-04 Available Marketed by WG Critical Care
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04) NDC 44567-0601-04 Available Marketed by WG Critical Care
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24) NDC 44567-0602-24 Available Marketed by WG Critical Care
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24) NDC 44567-0603-24 Available Marketed by WG Critical Care
Manufacturer: Hikma Pharmaceuticals USA, Inc. 📞 800-631-2174 1 NDC click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25) NDC 00143-9532-25 Unavailable Product temporarily on backorder. Additional lots will be available in the September 2026 timeframe. Demand increase for the drug
Manufacturer: Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) 📞 See Related Information section below for customer service information 1 NDC click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02) NDC 83634-0600-02 Available Distributed by Avenacy; Contact information: 877-283-6229
Manufacturer: Jiangsu Hengrui Pharmaceuticals Co., Ltd. 📞 See Related Information section below for customer service information 3 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (NDC 0781-3494-95) NDC 00781-3494-95 Available Marketed by Sandoz Inc.; Customer service: 800-525-8747
Current Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (NDC 0781-3495-95) NDC 00781-3495-95 Available Marketed by Sandoz Inc.; Customer service: 800-525-8747
Current Dexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95) NDC 00781-3493-95 Available Marketed by Sandoz Inc.; Customer service: 800-525-8747
Manufacturer: Meitheal Pharmaceuticals, Inc. 📞 844-824-8426 1 NDC click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03) NDC 71288-0505-03 Available
Manufacturer: Mylan Institutional, a Viatris Company 📞 800-796-9526 3 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) NDC 67457-0251-02 Available
Current Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) NDC 67457-0924-50 Available
Current Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) NDC 67457-0925-10 Available
Manufacturer: Par Health, USA LLC 📞 800-828-9393 3 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) NDC 42023-0186-20 Unavailable Estimated recovery: TBD; Please check wholesalers for inventory Other
Current Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) NDC 42023-0187-10 Unavailable Estimated recovery: TBD; Please check wholesalers for inventory Other
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) NDC 42023-0146-25 Available Please check wholesalers for inventory
Manufacturer: Pfizer Inc. 📞 844-646-4398 14 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01) NDC 00409-2815-01 Available
Current Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20) NDC 00409-1660-20 Available
Current Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12) NDC 00409-7875-12 Available
Current Precedex, Injection, 400 mcg/100 mL (NDC 0409-7853-24) NDC 00409-7853-24 Available
Current Precedex, Injection, 200 mcg/50 mL (NDC 0409-7838-24) NDC 00409-7838-24 Available
Current Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20) NDC 00409-1454-20 Available
Current Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01) NDC 00409-1434-01 Available
Current Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20) NDC 00409-4596-20 Available
Current Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02) NDC 00409-1638-02 Available
Current Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02) NDC 00409-0155-02 Available
Current Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50) NDC 00409-1660-50 Available
Current Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10) NDC 00409-3301-10 Available
Current Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10) NDC 00409-1174-10 Available
Current Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) NDC 00409-1596-10 Available
Manufacturer: Slayback Pharma 📞 800-461-7449 2 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
To Be Discontinued Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06) NDC 71225-0126-06 Discontinuation of the manufacture of the drug
To Be Discontinued Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05) NDC 71225-0126-05 Discontinuation of the manufacture of the drug
Manufacturer: Somerset Therapeutics, LLC 📞 732-554-1037 2 NDCS click to expand
Status NDC / product Strength / size Availability Related information Reason
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-758-04) NDC 70069-0758-04 Available
Current Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04) NDC 70069-0759-04 Available

These rows are manufacturer reports to the FDA for Dexmedetomidine Hydrochloride Injection — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Dexmedetomidine Hydrochloride Injection? options further down this page.

Why is Dexmedetomidine Hydrochloride Injection in shortage?

Dexmedetomidine is on the FDA shortage list because several manufacturers are running into different problems at the same time. For Fresenius Kabi, a few of their 4 mcg/mL vial sizes are being held up due to shipping delays, and their 100 mcg/mL vial is in short supply because more people need it than usual — no firm recovery date has been given for any of these. Baxter's 200 mcg/50 mL bag (NDC 0338-9555-24) is also currently unavailable, with an estimated return to supply around September 2026. On top of that, the notes mention that at least one 100 mcg/mL product marketed by WG Critical Care is temporarily on backorder, with additional supply expected in the September 2026 timeframe, and at least one 4 mcg/mL product line is being permanently discontinued by its maker.

The good news is that several strengths and package sizes from multiple manufacturers — including Pfizer's full Precedex line, Baxter's other bag sizes, Sandoz, Somerset Therapeutics, and Gland Pharma — are currently listed as available. So while some specific products are affected, not every version of this medication is in short supply right now.

FDA reason code(s): Other; Delay in shipping of the drug; Discontinuation of the manufacture of the drug; Demand increase for the drug

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Dexmedetomidine Hydrochloride Injection, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Dexmedetomidine Hydrochloride Injection?

Dexmedetomidine hydrochloride injection is currently on the FDA drug-shortage list. This is a medicine used in hospital and clinical settings, and I want to walk you through what the reported data shows so you know where things stand.

Every strength on this record still has an available source right now — 20 of 20 strengths are covered, and 13 of the 17 manufacturers on this record are still reporting supply. That includes strengths such as the 80 mcg/20 mL, 100 mcg/1 mL, 200 mcg/50 mL, 400 mcg/100 mL, and the 4 mcg/mL concentrations. A few specific products from certain makers are marked unavailable — for example, some 4 mcg/1 mL and 100 mcg/1 mL items from Fresenius Kabi, and Baxter's 200 ug/50 mL (estimated recovery September 2026). One maker, Accord, has discontinued its 100 ug/1 mL product. Reported reasons across the record include shipping delays, a demand increase, and some discontinuations.

Because this medicine is given by your care team, here is what to keep in mind:

  • Do not stop, skip, or change how you receive this medicine on your own.
  • Since your strength likely still has supply, your pharmacy or clinic can check wholesalers and other manufacturers to order it.
  • The same medicine is made by several other companies (for example Hikma, Sagent, Sun, Amneal, and others), so your pharmacy may be able to source one — though it may not be in local stock.
  • If a specific product is discontinued or cannot be found, ask your prescriber or pharmacist about options.

Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls. This is general national information and may not match local stock.

See “Where else can I get Dexmedetomidine Hydrochloride Injection?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Keep reading
Our full Dexmedetomidine guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Dexmedetomidine guide →

Where else can I get Dexmedetomidine Hydrochloride Injection?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Dexmedetomidine Hydrochloride Injection is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Injection, Solution · Intravenous Hikma Pharmaceuticals USA Inc. 00143-9198-10
Precedex DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Injection, Solution · Intravenous Hospira, Inc. 00409-1596-01
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Injection, Solution · Intravenous Sagent Pharmaceuticals 25021-0615-50
Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Injection · Intravenous Sagent Pharmaceuticals 25021-0617-82
Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/50mL Injection · Intravenous Baxter Healthcare Company 43066-0561-24
Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE 400 ug/100mL Injection · Intravenous Baxter Healthcare Company 43066-0565-12
Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Injection, Solution · Intravenous Sun Pharmaceuticals Industries, Inc. 57664-0596-50
Dexmedetomidine DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/2mL Injection, Solution · Intravenous Piramal Critical Care Inc 66794-0233-42
Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Injection · Intravenous Piramal Critical Care Inc 66794-0234-44
Dexmedetomidine Hydrochloride In Sodium Chloride DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Injection, Solution · Intravenous Precision Dose, Inc. 68094-0147-20
Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Injection · Intravenous Amneal Pharmaceuticals LLC 70121-1711-02

Alternative dosage forms of Dexmedetomidine Hydrochloride

A different form of the same drug (for example a solution when capsules are short). A form change is a clinical decision — ask your prescriber:

Therapeutic equivalents & pricing 30 productsclick to expand

Orange Book–rated equivalents of the affected strengths / sizes, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Dexmedetomidine HCl 100 ug/mLNDC 00143-9532-25 Hikma 25 vials AP FDA listed
Precedex 100 ug/mLNDC 00404-9938-02 Henry 1 vial AP FDA listed
Precedex 100 ug/mLNDC 00409-1638-02 Hospira, 25 vials AP FDA listed
Dexmedetomidine 100 ug/mLNDC 16729-0239-93 Accord 25 vials AP FDA listed
Dexmedetomidine Hydrochloride 100 ug/mLNDC 36000-0262-05 Baxter 5 vials AP FDA listed
Dexmedetomidine Hydrochloride 100 ug/mLNDC 42023-0146-25 Par 25 vials AP FDA listed
Dexmedetomidine 100 ug/mLNDC 55150-0209-02 Eugia 25 vials AP FDA listed
Dexmedetomidine Hydrochloride 100 ug/mLNDC 57664-0596-50 Sun 25 vials AP FDA listed
Dexmedetomidine Hydrochloride 100 ug/mLNDC 63323-0421-02 Fresenius 25 vials AP FDA listed
Dexmedetomidine Hydrochloride 100 ug/mLNDC 65219-0642-02 Fresenius 25 vials AP FDA listed
Dexmedetomidine 200 ug/2mLNDC 66794-0230-42 Piramal 25 vials AP FDA listed
Dexmedetomidine 200 ug/2mLNDC 66794-0233-42 Piramal 25 vials AP FDA listed
Dexmedetomidine 100 ug/mLNDC 67457-0251-02 Mylan 25 vials AP FDA listed
Dexmedetomidine 100 ug/mLNDC 68083-0527-25 Gland 25 vials AP FDA listed
Dexmedetomidine 100 ug/mLNDC 71288-0505-03 Meitheal 25 vials AP FDA listed
Dexmedetomidine hydrochloride 100 ug/mLNDC 71872-7030-01 Medical 1 vial AP FDA listed
Dexmedetomidine Hydrochloride 100 ug/mLNDC 71872-7031-01 Medical 1 vial AP FDA listed
Dexmedetomidine Hydrochloride 100 ug/mLNDC 71872-7122-01 Medical 1 vial AP FDA listed
Dexmedetomidine HCl 100 ug/mLNDC 71872-7218-01 Medical 1 vial AP FDA listed
Dexmedetomidine 200 ug/2mLNDC 71872-7323-01 Medical 1 vial AP FDA listed
Dexmedetomidine 100 ug/mLNDC 83634-0600-02 Avenacy 25 vials AP FDA listed
Dexmedetomidine 200 ug/2mLNDC 84549-0230-42 ProPharma 2 ml AP FDA listed
Dexmedetomidine 100 ug/mLNDC 84549-0505-03 ProPharma 2 ml AP FDA listed
Dexmedetomidine 100 ug/mLNDC 44567-0601-04 WG 4 vials AP FDA listed
Dexmedetomidine 100 ug/mLNDC 44567-0600-04 WG 4 vials AP FDA listed
Dexmedetomidine 100 ug/mLNDC 16729-0432-93 Accord 25 vials AP Discontinued
Dexmedetomidine Hydrochloride 4 ug/mLNDC 00143-9526-10 Hikma 10 pouches AP FDA listed
Dexmedetomidine Hydrochloride 200 ug/50mLNDC 00338-9555-24 Baxter 50 ml AP FDA listed
Precedex 4 ug/mLNDC 00409-1454-20 Hospira, 20 bottles AP FDA listed
Precedex 4 ug/mLNDC 00409-1660-10 Hospira, 10 bottles AP FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Dexmedetomidine Hydrochloride Injection — that fall in the same broad treatment class (sedative-hypnotics,non-barbiturate) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

GCN Seq No 044671
GCN 42360
HICL code 051104
Ingredient (HICL) Dexmedetomidine Hcl/Pf
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2E
Therapeutic class — specific (HIC3) Sedative-Hypnotics,Non-Barbiturate
AHFS code 28:24.92.00
AHFS class Anxiolytics,Sedatives,And Hypnotics,Misc
FDB label name DEXMEDETOMIDINE 200 MCG/2 ML
FDB brand name Dexmedetomidine Hcl
Legend status F — Federal legend — prescription drug or device
GPI-1460206030102020
GPI classDexmedetomidine HCl
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other anesthesia shortages

Dexmedetomidine Hydrochloride Injection shortage FAQs

Is Dexmedetomidine Hydrochloride Injection in shortage?
Yes — the FDA currently lists Dexmedetomidine Hydrochloride Injection in shortage (status: “Current”, first reported Apr 10, 2020). 59 of 59 products are affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Why is Dexmedetomidine Hydrochloride Injection in shortage?
The manufacturer-reported reason on file with the FDA: Other; Delay in shipping of the drug; Discontinuation of the manufacture of the drug. Product temporarily on backorder. Additional lots will be available in the September 2026 timeframe.
Which products are affected?
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) (NDC 16729-0239-93); Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93) (NDC 16729-0432-93); Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) (NDC 16729-0239-93). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Dexmedetomidine Hydrochloride Injection be available again?
The manufacturer reports: Product temporarily on backorder. Additional lots will be available in the September 2026 timeframe. The FDA does not publish a single guaranteed restock date — confirm with your pharmacy.
Can I still get Dexmedetomidine Hydrochloride somewhere?
Other manufacturers (Hikma Pharmaceuticals USA Inc., Hospira, Inc., Sagent Pharmaceuticals and others) still market it and have not reported a shortage. 2 alternative dosage forms of Dexmedetomidine Hydrochloride are also listed. See “Where else can I get Dexmedetomidine Hydrochloride Injection?” above — stock still varies by pharmacy.
What should I do if I take Dexmedetomidine Hydrochloride Injection?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out.

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How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
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