{
 "generic_name": "Dexmedetomidine Hydrochloride Injection",
 "slug": "dexmedetomidine-hydrochloride-injection",
 "brand_names": [
  "Dexmedetomidine",
  "Dexmedetomidine Hydrochloride",
  "Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride",
  "Dexmedetomidine In Dextrose",
  "Precedex"
 ],
 "fda_status": [
  "Current",
  "To Be Discontinued"
 ],
 "last_fda_update": "09/21/2026",
 "first_posted": "04/10/2020",
 "synced_at": "2026-10-01T04:04:04.751Z",
 "presentations": [
  {
   "company": "Fresenius Kabi USA, LLC",
   "package_ndc": "63323-671-20",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20)",
   "availability": "Unavailable",
   "availability_raw": "Unavailable",
   "fda_note": "Expected recovery: TBD"
  },
  {
   "company": "Fresenius Kabi USA, LLC",
   "package_ndc": "63323-671-50",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-50)",
   "availability": "Unavailable",
   "availability_raw": "Unavailable",
   "fda_note": "Estimated recovery: TBD"
  },
  {
   "company": "Fresenius Kabi USA, LLC",
   "package_ndc": "63323-671-00",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00)",
   "availability": "Unavailable",
   "availability_raw": "Unavailable",
   "fda_note": "Expected recovery: TBD"
  },
  {
   "company": "Par Health, USA LLC",
   "package_ndc": "42023-187-10",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10)",
   "availability": "Unavailable",
   "availability_raw": "Unavailable",
   "fda_note": "Estimated recovery: TBD; Please check wholesalers for inventory"
  },
  {
   "company": "Par Health, USA LLC",
   "package_ndc": "42023-186-20",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20)",
   "availability": "Unavailable",
   "availability_raw": "Unavailable",
   "fda_note": "Estimated recovery: TBD; Please check wholesalers for inventory"
  },
  {
   "company": "Amneal Pharmaceuticals",
   "package_ndc": "70121-1388-8",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Inventory available 4 to 5 month as per current demand. Next supply: week of 06/29/2026"
  },
  {
   "company": "Amneal Pharmaceuticals",
   "package_ndc": "70121-1389-7",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Eugia US LLC",
   "package_ndc": "55150-297-10",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Check wholesalers for inventory"
  },
  {
   "company": "Eugia US LLC",
   "package_ndc": "55150-296-10",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Check wholesalers for inventory"
  },
  {
   "company": "Gland Pharma Limited",
   "package_ndc": "43598-976-58",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Distributed by DRL"
  },
  {
   "company": "Gland Pharma Limited",
   "package_ndc": "43598-975-58",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Distributed by DRL"
  },
  {
   "company": "HQ Specialty Pharma",
   "package_ndc": "44567-602-24",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Marketed by WG Critical Care"
  },
  {
   "company": "HQ Specialty Pharma",
   "package_ndc": "44567-603-24",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Marketed by WG Critical Care"
  },
  {
   "company": "Slayback Pharma",
   "package_ndc": "71225-126-05",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05)",
   "availability": "Not specified",
   "availability_raw": null,
   "fda_note": "Discontinuation of the manufacture of the drug"
  },
  {
   "company": "Slayback Pharma",
   "package_ndc": "71225-126-06",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06)",
   "availability": "Not specified",
   "availability_raw": null,
   "fda_note": "Discontinuation of the manufacture of the drug"
  },
  {
   "company": "Amneal Pharmaceuticals",
   "package_ndc": "70121-1388-1",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.",
   "package_ndc": "0781-3493-95",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Marketed by Sandoz Inc.; Customer service: 800-525-8747"
  },
  {
   "company": "Amneal Pharmaceuticals",
   "package_ndc": "70121-1389-1",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Accord Healthcare Inc.",
   "package_ndc": "16729-432-93",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93)",
   "availability": "Unavailable",
   "availability_raw": "Unavailable",
   "fda_note": "Discontinuation of the manufacture of the drug"
  },
  {
   "company": "Fresenius Kabi USA, LLC",
   "package_ndc": "63323-421-02",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02)",
   "availability": "Unavailable",
   "availability_raw": "Unavailable",
   "fda_note": "Estimated recovery: TBD"
  },
  {
   "company": "Hikma Pharmaceuticals USA, Inc.",
   "package_ndc": "0143-9532-25",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25)",
   "availability": "Unavailable",
   "availability_raw": "Unavailable",
   "fda_note": "Product temporarily on backorder.  Additional lots will be available in the September 2026 timeframe."
  },
  {
   "company": "Eugia US LLC",
   "package_ndc": "55150-209-02",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Check wholesalers for inventory"
  },
  {
   "company": "HQ Specialty Pharma",
   "package_ndc": "44567-600-04",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Marketed by WG Critical Care"
  },
  {
   "company": "HQ Specialty Pharma",
   "package_ndc": "44567-601-04",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Marketed by WG Critical Care"
  },
  {
   "company": "Meitheal Pharmaceuticals, Inc.",
   "package_ndc": "71288-505-03",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Mylan Institutional, a Viatris Company",
   "package_ndc": "67457-251-02",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Par Health, USA LLC",
   "package_ndc": "42023-146-25",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Please check wholesalers for inventory"
  },
  {
   "company": "Somerset Therapeutics, LLC",
   "package_ndc": "70069-758-04",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-758-04)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Somerset Therapeutics, LLC",
   "package_ndc": "70069-759-04",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Accord Healthcare Inc.",
   "package_ndc": "16729-239-93",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93)",
   "availability": "Not specified",
   "availability_raw": null,
   "fda_note": "Discontinuation of the manufacture of the drug"
  },
  {
   "company": "Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.)",
   "package_ndc": "83634-600-02",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Distributed by Avenacy; Contact information: 877-283-6229"
  },
  {
   "company": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.",
   "package_ndc": "0781-3494-95",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (NDC 0781-3494-95)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Marketed by Sandoz Inc.; Customer service: 800-525-8747"
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-7838-24",
   "presentation": "Precedex, Injection, 200 mcg/50 mL (NDC 0409-7838-24)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Gland Pharma Limited",
   "package_ndc": "66794-230-42",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Marketed by Piramal Critical Care Inc.: 800-414-1901"
  },
  {
   "company": "Baxter Healthcare",
   "package_ndc": "0338-9555-24",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24)",
   "availability": "Unavailable",
   "availability_raw": "Unavailable",
   "fda_note": "Estimated recovery: September 2026"
  },
  {
   "company": "Baxter Healthcare",
   "package_ndc": "43066-555-24",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Mylan Institutional, a Viatris Company",
   "package_ndc": "67457-924-50",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.",
   "package_ndc": "0781-3495-95",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (NDC 0781-3495-95)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Marketed by Sandoz Inc.; Customer service: 800-525-8747"
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-7853-24",
   "presentation": "Precedex, Injection, 400 mcg/100 mL (NDC 0409-7853-24)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Baxter Healthcare",
   "package_ndc": "43066-557-12",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Baxter Healthcare",
   "package_ndc": "0338-9557-12",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Mylan Institutional, a Viatris Company",
   "package_ndc": "67457-925-10",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-7875-12",
   "presentation": "Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-2815-01",
   "presentation": "Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-1434-01",
   "presentation": "Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Azurity Pharmaceuticals, Inc",
   "package_ndc": "52536-125-10",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Distributed by Wilshire Pharmaceuticals, Inc."
  },
  {
   "company": "Azurity Pharmaceuticals, Inc",
   "package_ndc": "72572-127-10",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Distributed by Civica"
  },
  {
   "company": "Azurity Pharmaceuticals, Inc",
   "package_ndc": "52536-126-08",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Distributed by Wilshire Pharmaceuticals, Inc."
  },
  {
   "company": "Azurity Pharmaceuticals, Inc",
   "package_ndc": "72572-128-08",
   "presentation": "Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": "Distributed by Civica"
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-1638-02",
   "presentation": "Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-1454-20",
   "presentation": "Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-1660-50",
   "presentation": "Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-4596-20",
   "presentation": "Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-0155-02",
   "presentation": "Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-1174-10",
   "presentation": "Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-1596-10",
   "presentation": "Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-1660-20",
   "presentation": "Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  },
  {
   "company": "Pfizer Inc.",
   "package_ndc": "0409-3301-10",
   "presentation": "Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10)",
   "availability": "Available",
   "availability_raw": "Available",
   "fda_note": null
  }
 ],
 "changes": []
}