Medicine
Dexmedetomidine 1000 mcg/10 mL injection
Dexmedetomidine 1000 mcg/10 mL injection is a generic prescription medicine for intravenous use, made by 2 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 vials at 20℃ to 25°C (68℉ to 77°F), excursions permitted 15℃ to 30°C…
Key facts
- Active ingredient (INN)
- Dexmedetomidine
- Brand
- Sold under the generic name
- Strength
- 1000 mcg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 4 vials of 10 mL
- Manufacturers
- Somerset TherapeuticsWG Critical Care
- Origin register
- US FDA, United States
- Storage
- Store vials at 20℃ to 25°C (68℉ to 77°F), excursions permitted 15℃ to 30°C (59℉ to 86°F). Protect from light.
- 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, 1788947DailyMed set ID 0d2710f2-ee47-4114-ab5c-8dca74cdcb8d, 649e777b-9b30-4f1e-9fb9-6bba57580976NDC 44567-601, 70069-759Application NDA206628, ANDA218112
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 |
|---|---|---|---|
| 4 vial in 1 carton / 10 mL in 1 vial | 70069-759-04 | Somerset Therapeutics | 26 September 2024 |
| 4 vial in 1 carton / 10 mL in 1 vial | 44567-601-04 | WG Critical Care | 26 January 2017 |
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
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
Need Dexmedetomidine 1000 mcg/10 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.