Medicine
Dotarem 5653.5 mg/15 mL injection
Dotarem 5653.5 mg/15 mL injection is a prescription medicine containing Gadoterate for intravenous use, marketed by Guerbet, 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 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)…
Key facts
- Active ingredient (INN)
- Gadoterate
- Brand
- Dotarem
- Strength
- 5653.5 mg/15 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 15 mL, 10 syringes of 15 mL
- Marketing authorisation holder
- Guerbet
- Manufacturer
- Guerbet
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Should solidification occur in the vial because of exposure to the cold, bring DOTAREM to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, DOTAREM should return to a clear, colorless to yellow solution.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V08CA02 Gadoterate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 March 2013
- Identifiers
- DailyMed set ID e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebcNDC 67684-2000, 67684-2001, 67684-3001Application NDA204781
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
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 20 March 2013 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 Gadoterate 5653.5 mg/15 mL injection.
Other strengths and forms of Gadoterate
Clinical summary
Gadoterate is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Gadoterate 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 GadoterateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DOTAREM prescribing information (Guerbet) · U.S. National Library of Medicine, DailyMed
Need Dotarem 5653.5 mg/15 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.