{ "drug": "Dexmedetomidine Hydrochloride Injection", "asOf": "2026-08-25", "status": "in-shortage", "since": "04/10/2020", "dayN": 2328, "cat": "Anesthesia", "companies": [ "Eugia US LLC", "Baxter Healthcare", "Pfizer Inc.", "HQ Specialty Pharma", "Par Health, USA LLC", "Fresenius Kabi USA, LLC", "Slayback Pharma", "Jiangsu Hengrui Pharmaceuticals Co., Ltd.", "Gland Pharma Limited", "Mylan Institutional, a Viatris Company", "Amneal Pharmaceuticals", "Meitheal Pharmaceuticals, Inc.", "Somerset Therapeutics, LLC", "Azurity Pharmaceuticals, Inc", "Accord Healthcare Inc.", "Hikma Pharmaceuticals USA, Inc.", "Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.)" ], "reasons": [ "Other", "Delay in shipping of the drug", "Discontinuation of the manufacture of the drug", "Demand increase for the drug" ], "records": [ { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "55150-297-10", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "888-238-7880", "availability": "Available", "related_info": "Check wholesalers for inventory", "openfda": { "application_number": [ "ANDA210321" ], "brand_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE" ], "manufacturer_name": [ "Eugia US LLC" ], "product_ndc": [ "55150-297", "55150-209", "55150-296" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "309710", "1718906", "1718909" ], "spl_id": [ "a1eab62d-fcef-4b83-9266-3c5f7a05927b" ], "spl_set_id": [ "8c162541-986b-4b30-866c-b2631ba2c975" ], "package_ndc": [ "55150-209-02", "55150-296-10", "55150-297-10" ], "unii": [ "1018WH7F9I" ] }, "update_date": "08/06/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10)", "company_name": "Eugia US LLC", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "43066-557-12", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "888-229-0001", "availability": "Available", "openfda": { "application_number": [ "ANDA208532" ], "brand_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE" ], "manufacturer_name": [ "Baxter Healthcare Company" ], "product_ndc": [ "43066-557", "43066-555" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "1718906", "1718909" ], "spl_id": [ "d0910ea1-c3e1-44f8-b8b5-1f39ffd43290" ], "spl_set_id": [ "aea9a3ad-c244-42be-9cd3-5df83fe2b522" ], "package_ndc": [ "43066-555-24", "43066-557-12" ], "unii": [ "1018WH7F9I" ] }, "update_date": "08/17/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12)", "company_name": "Baxter Healthcare", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "0409-1638-02", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "844-646-4398", "availability": "Available", "openfda": { "application_number": [ "NDA021038" ], "brand_name": [ "PRECEDEX" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "manufacturer_name": [ "Hospira, Inc." ], "product_ndc": [ "0409-1638", "0409-1660", "0409-1434", "0409-1596", "0409-7838", "0409-7853", "0409-7875" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "284397", "309710", "1718900", "1718902", "1718906", "1718907", "1718909", "1718910", "2396891", "2396892" ], "spl_id": [ "3c5274fd-6597-4b88-babc-92e4e16c6329" ], "spl_set_id": [ "548a88c0-afda-427e-75ac-5af0cfa2224c" ], "package_ndc": [ "0409-1660-55", "0409-1660-50", "0409-1660-35", "0409-1660-10", "0409-1660-22", "0409-1660-20", "0409-1638-32", "0409-1638-02", "0409-1434-01", "0409-1596-01", "0409-1596-10", "0409-7838-01", "0409-7838-24", "0409-7853-01", "0409-7853-24", "0409-7875-01", "0409-7875-12" ], "unii": [ "1018WH7F9I" ] }, "update_date": "08/07/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02)", "company_name": "Pfizer Inc.", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "0409-7875-12", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "844-646-4398", "availability": "Available", "openfda": { "application_number": [ "NDA021038" ], "brand_name": [ "PRECEDEX" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "manufacturer_name": [ "Hospira, Inc." ], "product_ndc": [ "0409-7875", "0409-1660", "0409-1638", "0409-1434", "0409-1596", "0409-7838", "0409-7853" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "284397", "309710", "1718900", "1718902", "1718906", "1718907", "1718909", "1718910", "2396891", "2396892" ], "spl_id": [ "3c5274fd-6597-4b88-babc-92e4e16c6329" ], "spl_set_id": [ "548a88c0-afda-427e-75ac-5af0cfa2224c" ], "package_ndc": [ "0409-1660-55", "0409-1660-50", "0409-1660-35", "0409-1660-10", "0409-1660-22", "0409-1660-20", "0409-1638-32", "0409-1638-02", "0409-1434-01", "0409-1596-01", "0409-1596-10", "0409-7838-01", "0409-7838-24", "0409-7853-01", "0409-7853-24", "0409-7875-01", "0409-7875-12" ], "unii": [ "1018WH7F9I" ] }, "update_date": "08/07/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12)", "company_name": "Pfizer Inc.", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "44567-603-24", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "WG Critical Care 888-493-0861", "availability": "Available", "related_info": "Marketed by WG Critical Care", "openfda": { "application_number": [ "NDA206628" ], "brand_name": [ "DEXMEDETOMIDINE IN DEXTROSE" ], "generic_name": [ "DEXMEDETOMIDINE" ], "manufacturer_name": [ "WG Critical Care, LLC" ], "product_ndc": [ "44567-603", "44567-600", "44567-601", "44567-602" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "1718906", "1718909", "1788947" ], "spl_id": [ "42a0bb50-be84-4c46-abfd-fd44c6f10087" ], "spl_set_id": [ "0d2710f2-ee47-4114-ab5c-8dca74cdcb8d" ], "package_ndc": [ "44567-600-04", "44567-601-04", "44567-602-24", "44567-603-24" ], "unii": [ "1018WH7F9I" ] }, "update_date": "08/17/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24)", "company_name": "HQ Specialty Pharma", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "42023-187-10", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "800-828-9393", "availability": "Unavailable", "related_info": "Estimated recovery: TBD; Please check wholesalers for inventory", "openfda": { "application_number": [ "ANDA208266" ], "brand_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "manufacturer_name": [ "Par Health USA, LLC" ], "product_ndc": [ "42023-187", "42023-146", "42023-186" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "309710", "1718906", "1718909" ], "spl_id": [ "54174211-6684-4fb9-a605-be12b94e2948" ], "spl_set_id": [ "1ee59985-4c1d-48f7-b8f9-5584c2d55e08" ], "package_ndc": [ "42023-146-25", "42023-186-20", "42023-187-10" ], "unii": [ "1018WH7F9I" ] }, "update_date": "08/18/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10)", "company_name": "Par Health, USA LLC", "shortage_reason": "Other", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "63323-671-00", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "888-386-1300", "availability": "Unavailable", "related_info": "Expected recovery: TBD", "update_date": "08/04/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00)", "company_name": "Fresenius Kabi USA, LLC", "shortage_reason": "Delay in shipping of the drug", "status": "Current" }, { "discontinued_date": "06/05/2026", "update_type": "New", "initial_posting_date": "06/05/2026", "package_ndc": "71225-126-05", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "800-461-7449", "related_info": "Discontinuation of the manufacture of the drug", "update_date": "06/05/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05)", "company_name": "Slayback Pharma", "status": "To Be Discontinued" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "0781-3493-95", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "See Related Information section below for customer service information", "availability": "Available", "related_info": "Marketed by Sandoz Inc.; Customer service: 800-525-8747", "openfda": { "application_number": [ "ANDA209065" ], "brand_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE" ], "manufacturer_name": [ "Sandoz Inc." ], "product_ndc": [ "0781-3493", "0781-3494", "0781-3495" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "1718900", "1718906", "1718909" ], "spl_id": [ "fdf227d9-008e-60f8-e053-6294a90af5c4" ], "spl_set_id": [ "809e8f77-390f-4cc8-8c8a-4f67a249c9df" ], "package_ndc": [ "0781-3493-95", "0781-3494-95", "0781-3495-95" ], "unii": [ "1018WH7F9I" ] }, "update_date": "07/30/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95)", "company_name": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "0409-1660-50", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "844-646-4398", "availability": "Available", "openfda": { "application_number": [ "NDA021038" ], "brand_name": [ "PRECEDEX" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "manufacturer_name": [ "Hospira, Inc." ], "product_ndc": [ "0409-1660", "0409-1638", "0409-1434", "0409-1596", "0409-7838", "0409-7853", "0409-7875" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "284397", "309710", "1718900", "1718902", "1718906", "1718907", "1718909", "1718910", 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"ANDA209307" ], "brand_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "manufacturer_name": [ "Dr.Reddy's Laboratories Inc" ], "product_ndc": [ "43598-975", "43598-976" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "1718906", "1718909" ], "spl_id": [ "5785a11f-7784-4ae0-8029-f50b782eaf4a" ], "spl_set_id": [ "d174c19d-56f1-4ef4-087c-23c26db8e40b" ], "package_ndc": [ "43598-976-11", "43598-976-58", "43598-975-11", "43598-975-58" ], "unii": [ "1018WH7F9I" ] }, "update_date": "07/22/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58)", "company_name": "Gland Pharma Limited", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "0409-1174-10", "generic_name": "Dexmedetomidine 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(NDC 0409-1174-10)", "company_name": "Pfizer Inc.", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "67457-251-02", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "800-796-9526", "availability": "Available", "openfda": { "application_number": [ "ANDA202881" ], "brand_name": [ "DEXMEDETOMIDINE" ], "generic_name": [ "DEXMEDETOMIDINE" ], "manufacturer_name": [ "Mylan Institutional LLC" ], "product_ndc": [ "67457-251" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "309710" ], "spl_id": [ "afa561b9-9d6c-47b3-87e6-8d049597a0ed" ], "spl_set_id": [ "ebdfe2e8-30ca-4f18-935a-41bcbbce4937" ], "package_ndc": [ "67457-251-00", "67457-251-02" ], "unii": [ "1018WH7F9I" ] }, "update_date": "08/20/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, 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Next supply: week of 06/29/2026", "openfda": { "application_number": [ "ANDA207551" ], "brand_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC" ], "product_ndc": [ "70121-1388", "70121-1389" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "1718906", "1718909" ], "spl_id": [ "af193b53-1488-401f-8f06-cc193297c4a8" ], "spl_set_id": [ "eb1ba463-ab42-4f49-9ebe-3ad5af108326" ], "package_ndc": [ "70121-1388-1", "70121-1388-8", "70121-1389-1", "70121-1389-7" ], "unii": [ "1018WH7F9I" ] }, "update_date": "06/17/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8)", "company_name": "Amneal Pharmaceuticals", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": 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Additional lots will be available in the September 2026 timeframe.", "openfda": { "application_number": [ "ANDA205046" ], "brand_name": [ "DEXMEDETOMIDINE HCL" ], "generic_name": [ "DEXMEDETOMIDINE HCL" ], "manufacturer_name": [ "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "0143-9532" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "rxcui": [ "309710" ], "spl_id": [ "8cb1c4c8-48b4-471f-b443-5f03896a3fb7" ], "spl_set_id": [ "de6f01a2-9f2d-4c68-9c02-06643704acb1" ], "package_ndc": [ "0143-9532-01", "0143-9532-25" ], "unii": [ "1018WH7F9I" ] }, "update_date": "08/13/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25)", "company_name": "Hikma Pharmaceuticals USA, Inc.", "shortage_reason": "Demand increase for the drug", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "63323-671-20", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "888-386-1300", "availability": "Unavailable", "related_info": "Expected recovery: TBD", "update_date": "08/04/2026", "therapeutic_category": [ "Anesthesia" ], "dosage_form": "Injection", "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20)", "company_name": "Fresenius Kabi USA, LLC", "shortage_reason": "Other", "status": "Current" }, { "update_type": "Reverified", "initial_posting_date": "04/10/2020", "package_ndc": "0409-1434-01", "generic_name": "Dexmedetomidine Hydrochloride Injection", "contact_info": "844-646-4398", "availability": "Available", "openfda": { "application_number": [ "NDA021038" ], "brand_name": [ "PRECEDEX" ], "generic_name": [ "DEXMEDETOMIDINE HYDROCHLORIDE" ], "manufacturer_name": [ "Hospira, Inc." ], "product_ndc": [ "0409-1434", "0409-1660", "0409-1638", "0409-1596", "0409-7838", 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