Medicine
Dexmedetomidine 200 mcg/50 mL injection
Dexmedetomidine 200 mcg/50 mL injection is a generic prescription medicine for intravenous use, made by 15 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Dexmedetomidine
- Brand
- Sold under the generic name
- Strength
- 200 mcg/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 50 mL, 10 pouches of 50 mL, 20 vials of 50 mL and 16 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaEugiaIndiaGland PharmaIndiaPiramal Critical CareIndiaAmneal PharmaceuticalsBaxter HealthcareCivicaHikma PharmaceuticalsMylan InstitutionalPar Health
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05CM18 Dexmedetomidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 April 2016
- Identifiers
- RxCUI 1718906, 1718909, 309710 +3DailyMed set ID f550d2ba-49ac-4a3b-95db-692b468af479, d174c19d-56f1-4ef4-087c-23c26db8e40b, 8c162541-986b-4b30-866c-b2631ba2c975 +15NDC 52536-125, 43598-976, 55150-296 +15Application ANDA212791, ANDA209307, ANDA210321 +10
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial in 1 carton / 50 mL in 1 vial | 43598-976-58 | Dr. Reddy's LaboratoriesIndia | 17 August 2020 |
| 10 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag | 55150-296-10 | EugiaIndia | 7 December 2020 |
| 20 vial in 1 carton / 50 mL in 1 vial | 68083-238-20 | Gland PharmaIndia | 3 June 2020 |
| 20 vial in 1 carton / 50 mL in 1 vial | 66794-234-44 | Piramal Critical CareIndia | 1 April 2021 |
| 24 bag in 1 carton / 50 mL in 1 bag | 0338-9555-24 | Baxter Healthcare | 21 August 2018 |
| 24 bag in 1 carton / 50 mL in 1 bag | 43066-555-24 | Baxter Healthcare | 27 August 2019 |
| 24 bag in 1 carton / 50 mL in 1 bag | 43066-561-24 | Baxter Healthcare | 27 August 2019 |
| 20 bottle, glass in 1 carton / 50 mL in 1 bottle, glass | 70121-1388-8 | Amneal Pharmaceuticals | 20 May 2020 |
| 15 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag | 70121-1711-2 | Amneal Pharmaceuticals | 8 January 2024 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag | 70121-1711-9 | Amneal Pharmaceuticals | 19 May 2023 |
| 10 pouch in 1 case / 1 bag in 1 pouch / 50 mL in 1 bag | 0143-9526-10 | Hikma Pharmaceuticals | 30 January 2020 |
| 20 bottle in 1 carton / 50 mL in 1 bottle | 67457-924-50 | Mylan Institutional | 13 November 2020 |
| 20 vial in 1 carton / 50 mL in 1 vial | 42023-186-20 | Par Health | 4 December 2020 |
| 10 bottle in 1 carton / 50 mL in 1 bottle | 25021-615-50 | Sagent Pharmaceuticals | 15 February 2024 |
| 10 bottle in 1 carton / 50 mL in 1 bottle | 0781-3494-95 | Sandoz | 12 June 2020 |
| 24 bag in 1 carton / 50 mL in 1 bag | 44567-602-24 | WG Critical Care | 18 October 2018 |
| 10 bottle in 1 carton / 50 mL in 1 bottle | 52536-125-10 | Wilshire Pharmaceuticals | 30 January 2025 |
| 10 bottle in 1 carton / 50 mL in 1 bottle | 72572-127-10 | Civica | 23 August 2021 |
| 20 bottle in 1 carton / 50 mL in 1 bottle | 68094-147-20 | Precision Dose | 23 November 2020 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Dexmedetomidine 200 mcg/50 mL injection.
Other strengths and forms of Dexmedetomidine
Clinical summary
Dexmedetomidine is a central alpha-2 adrenergic agonist indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting, among other approved uses. MedsAcross supplies Dexmedetomidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DexmedetomidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Precedex prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
- Dexdor: European public assessment report (EPAR) · European Medicines Agency
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