CiteFacts · FDA Drug Shortages · FDA source
FDA shortage status: Dexmedetomidine Hydrochloride Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current, To Be Discontinued. First FDA posting: 2020-04-10. Latest FDA row update: 2026-10-06.
FDA lists 59 package records, with companies: Accord Healthcare Inc., Amneal Pharmaceuticals, Amneal Pharmaceuticals LLC, Avenacy Inc., Azurity Pharmaceuticals, Inc, Baxter Healthcare, CIVICA, INC., Dr.Reddy's Laboratories Inc, Eugia US LLC, Fresenius Kabi USA, LLC, Gland Pharma Limited, HQ Specialty Pharma, Hikma Pharmaceuticals USA, Inc., Hospira, Inc., Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.), Jiangsu Hengrui Pharmaceuticals Co., Ltd., Meitheal Pharmaceuticals Inc., Meitheal Pharmaceuticals, Inc., Mylan Institutional LLC, Mylan Institutional, a Viatris Company, Par Health USA, LLC, Par Health, USA LLC, Pfizer Inc., Piramal Critical Care Inc, Sandoz Inc., Slayback Pharma, Somerset Therapeutics, LLC, Wilshire Pharmaceuticals, Inc.. Package NDCs: 0143-9532-25, 0338-9555-24, 0338-9557-12, 0409-0155-02, 0409-1174-10, 0409-1434-01, 0409-1454-20, 0409-1596-10, 0409-1638-02, 0409-1660-20, 0409-1660-50, 0409-2815-01, 0409-3301-10, 0409-4596-20, 0409-7838-24, 0409-7853-24, 0409-7875-12, 0781-3493-95, 0781-3494-95, 0781-3495-95, 16729-239-93, 16729-432-93, 42023-146-25, 42023-186-20, 42023-187-10, 43066-555-24, 43066-557-12, 43598-975-58, 43598-976-58, 44567-600-04, 44567-601-04, 44567-602-24, 44567-603-24, 52536-125-10, 52536-126-08, 55150-209-02, 55150-296-10, 55150-297-10, 63323-421-02, 63323-671-00, 63323-671-20, 63323-671-50, 66794-230-42, 67457-251-02, 67457-924-50, 67457-925-10, 70069-758-04, 70069-759-04, 70121-1388-1, 70121-1388-8, 70121-1389-1, 70121-1389-7, 71225-126-05, 71225-126-06, 71288-505-03, 72572-127-10, 72572-128-08, 83634-600-02.
FDA shortage reason: Delay in shipping of the drug; Demand increase for the drug; Discontinuation of the manufacture of the drug; Other
This is nationwide FDA status, not local pharmacy inventory. CiteFacts does not provide medical, treatment, substitution, or dosing advice.
FDA package and manufacturer records
| Company | Package NDC | Presentation | FDA availability field | FDA update |
|---|---|---|---|---|
| Accord Healthcare Inc. | 16729-239-93 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) | Unavailable | 2026-09-15 |
| Accord Healthcare Inc. | 16729-239-93 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) | Not stated | 2026-04-21 |
| Accord Healthcare Inc. | 16729-432-93 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93) | Unavailable | 2026-09-15 |
| Amneal Pharmaceuticals | 70121-1389-1 | Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) | Available | 2026-10-05 |
| Amneal Pharmaceuticals | 70121-1388-1 | Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) | Available | 2026-10-05 |
| Amneal Pharmaceuticals | 70121-1388-8 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8) | Available | 2026-10-05 |
| Amneal Pharmaceuticals | 70121-1389-7 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7) | Available | 2026-10-05 |
| Azurity Pharmaceuticals, Inc | 52536-125-10 | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10) | Available | 2026-09-16 |
| Azurity Pharmaceuticals, Inc | 72572-127-10 | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10) | Available | 2026-09-16 |
| Azurity Pharmaceuticals, Inc | 52536-126-08 | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08) | Available | 2026-09-16 |
| Azurity Pharmaceuticals, Inc | 72572-128-08 | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) | Available | 2026-09-16 |
| Baxter Healthcare | 0338-9555-24 | Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) | Unavailable | 2026-08-17 |
| Baxter Healthcare | 43066-555-24 | Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) | Available | 2026-10-02 |
| Baxter Healthcare | 0338-9557-12 | Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) | Available | 2026-10-02 |
| Baxter Healthcare | 43066-557-12 | Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) | Available | 2026-10-02 |
| Eugia US LLC | 55150-209-02 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02) | Available | 2026-10-02 |
| Eugia US LLC | 55150-296-10 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10) | Available | 2026-10-02 |
| Eugia US LLC | 55150-297-10 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10) | Available | 2026-10-02 |
| Fresenius Kabi USA, LLC | 63323-421-02 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02) | Unavailable | 2026-10-06 |
| Fresenius Kabi USA, LLC | 63323-671-00 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00) | Unavailable | 2026-10-06 |
| Fresenius Kabi USA, LLC | 63323-671-20 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20) | Unavailable | 2026-10-06 |
| Fresenius Kabi USA, LLC | 63323-671-50 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-50) | Unavailable | 2026-10-06 |
| Gland Pharma Limited | 66794-230-42 | Dexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42) | Available | 2026-07-22 |
| Gland Pharma Limited | 43598-975-58 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58) | Available | 2026-07-22 |
| Gland Pharma Limited | 43598-976-58 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58) | Available | 2026-07-22 |
| HQ Specialty Pharma | 44567-600-04 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04) | Available | 2026-10-01 |
| HQ Specialty Pharma | 44567-601-04 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04) | Available | 2026-10-01 |
| HQ Specialty Pharma | 44567-602-24 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24) | Available | 2026-10-01 |
| HQ Specialty Pharma | 44567-603-24 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24) | Available | 2026-10-01 |
| Hikma Pharmaceuticals USA, Inc. | 0143-9532-25 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25) | Unavailable | 2026-09-18 |
| Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) | 83634-600-02 | Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02) | Unavailable | 2026-10-05 |
| Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 0781-3494-95 | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (NDC 0781-3494-95) | Available | 2026-10-05 |
| Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 0781-3495-95 | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (NDC 0781-3495-95) | Available | 2026-10-05 |
| Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 0781-3493-95 | Dexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95) | Available | 2026-10-05 |
| Meitheal Pharmaceuticals, Inc. | 71288-505-03 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03) | Available | 2026-08-27 |
| Mylan Institutional, a Viatris Company | 67457-251-02 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) | Available | 2026-10-05 |
| Mylan Institutional, a Viatris Company | 67457-924-50 | Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) | Available | 2026-10-05 |
| Mylan Institutional, a Viatris Company | 67457-925-10 | Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) | Available | 2026-10-05 |
| Par Health, USA LLC | 42023-146-25 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) | Available | 2026-08-18 |
| Par Health, USA LLC | 42023-186-20 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) | Unavailable | 2026-10-02 |
| Par Health, USA LLC | 42023-187-10 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) | Unavailable | 2026-10-02 |
| Pfizer Inc. | 0409-7875-12 | Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-2815-01 | Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-1434-01 | Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-1638-02 | Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02) | Available | 2026-09-08 |
| Pfizer Inc. | 0409-1454-20 | Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-1660-50 | Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-4596-20 | Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-7838-24 | Precedex, Injection, 200 mcg/50 mL (NDC 0409-7838-24) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-0155-02 | Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-1174-10 | Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-1596-10 | Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) | Available | 2026-08-24 |
| Pfizer Inc. | 0409-7853-24 | Precedex, Injection, 400 mcg/100 mL (NDC 0409-7853-24) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-1660-20 | Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20) | Available | 2026-09-21 |
| Pfizer Inc. | 0409-3301-10 | Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10) | Available | 2026-09-08 |
| Slayback Pharma | 71225-126-05 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05) | Not stated | 2026-06-05 |
| Slayback Pharma | 71225-126-06 | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06) | Not stated | 2026-06-05 |
| Somerset Therapeutics, LLC | 70069-758-04 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-758-04) | Available | 2026-09-11 |
| Somerset Therapeutics, LLC | 70069-759-04 | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04) | Available | 2026-09-11 |
Source facts
Grouped generic ingredient: Dexmedetomidine Hydrochloride Injection · 59 package records
Therapeutic categories: Anesthesia
Dosage forms: Injection
Routes: INTRAVENOUS
Open FDA source data · JSON · Markdown
FDA is authoritative. Source retrieved 2026-10-07T13:54:04+00:00. Derived grouping is documented in this record's derivations.