Medicine
Dexmedetomidine 400 mcg/100 mL injection
Dexmedetomidine 400 mcg/100 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
Do not freeze. Store at 25°C (77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Dexmedetomidine
- Brand
- Sold under the generic name
- Strength
- 400 mcg/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 100 mL, 10 pouches of 100 mL, 12 bags of 100 mL and 18 more
- Manufacturers
- Gland PharmaIndiaDr. Reddy's LaboratoriesIndiaEugiaIndiaPiramal Critical CareIndiaAmneal PharmaceuticalsBaxter HealthcareSagent PharmaceuticalsCivicaHikma PharmaceuticalsMylan Institutional
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 25°C (77°F), excursions permitted between 15° to 30°C (59° to 86°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 1718900, 1718906, 1718909 +3DailyMed set ID 809e8f77-390f-4cc8-8c8a-4f67a249c9df, f140de5a-f13d-46b4-a742-049c63e474f5, e9d5c989-ebf6-4377-9c6e-7aef848a03a1 +16NDC 0781-3495, 67457-925, 68094-247 +17Application ANDA209065, ANDA212571, ANDA212857 +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 / 100 mL in 1 vial | 68083-239-10 | Gland PharmaIndia | 3 June 2020 |
| 10 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 68083-657-10 | Gland PharmaIndia | 19 December 2024 |
| 10 vial in 1 carton / 100 mL in 1 vial | 43598-975-58 | Dr. Reddy's LaboratoriesIndia | 17 August 2020 |
| 10 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 55150-297-10 | EugiaIndia | 7 December 2020 |
| 10 vial in 1 carton / 100 mL in 1 vial | 66794-235-41 | Piramal Critical CareIndia | 1 April 2021 |
| 12 bag in 1 carton / 100 mL in 1 bag | 0338-9557-12 | Baxter Healthcare | 21 August 2018 |
| 12 bag in 1 carton / 100 mL in 1 bag | 43066-557-12 | Baxter Healthcare | 27 August 2019 |
| 12 bag in 1 carton / 100 mL in 1 bag | 43066-565-12 | Baxter Healthcare | 27 August 2019 |
| 10 bottle, glass in 1 carton / 100 mL in 1 bottle, glass | 70121-1389-7 | Amneal Pharmaceuticals | 20 May 2020 |
| 10 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 70121-1712-2 | Amneal Pharmaceuticals | 8 January 2024 |
| 12 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 70121-1712-3 | Amneal Pharmaceuticals | 19 May 2023 |
| 10 bottle in 1 carton / 100 mL in 1 bottle | 25021-615-51 | Sagent Pharmaceuticals | 15 February 2024 |
| 20 bag in 1 carton / 100 mL in 1 bag | 25021-617-82 | Sagent Pharmaceuticals | 15 July 2025 |
| 10 pouch in 1 bag / 1 bag in 1 pouch / 100 mL in 1 bag | 0143-9525-10 | Hikma Pharmaceuticals | 30 January 2020 |
| 10 bottle in 1 carton / 100 mL in 1 bottle | 67457-925-10 | Mylan Institutional | 13 November 2020 |
| 10 vial in 1 carton / 100 mL in 1 vial | 42023-187-10 | Par Health | 4 December 2020 |
| 10 bottle in 1 carton / 100 mL in 1 bottle | 0781-3495-95 | Sandoz | 12 June 2020 |
| 24 bag in 1 carton / 100 mL in 1 bag | 44567-603-24 | WG Critical Care | 18 October 2018 |
| 8 bottle in 1 carton / 100 mL in 1 bottle | 52536-126-08 | Wilshire Pharmaceuticals | 30 January 2025 |
| 8 bottle in 1 carton / 100 mL in 1 bottle | 72572-128-08 | Civica | 23 August 2021 |
| 10 bottle in 1 carton / 100 mL in 1 bottle | 68094-247-10 | 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 400 mcg/100 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
Need Dexmedetomidine 400 mcg/100 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.