Medicine
Gadoteridol 5586 mg/20 mL injection
Gadoteridol 5586 mg/20 mL injection is a generic prescription medicine for intravenous use, 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. Should freezing occur in the vial, Gadoteridol Injection, USP…
Key facts
- Active ingredient (INN)
- Gadoteridol
- Brand
- Sold under the generic name
- Strength
- 5586 mg/20 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 5 vials of 20 mL
- Manufacturer
- Slate Run Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- DO NOT FREEZE. Should freezing occur in the vial, Gadoteridol Injection, USP should be brought to room temperature before use. Store at 20° to 25°C (68° to77° F). Excursions permitted to 15°C to 30°C (59°F to 86°F). If allowed to stand at room temperature for a minimum of 60 minutes, Gadoteridol Injection, USP should return to a clear, colorless to slightly yellow solution. Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V08CA04 Gadoteridol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 February 2025
- Identifiers
- DailyMed set ID 538a70e0-061c-40d2-8447-5b7a4e61a55fNDC 70436-121Application ANDA218749
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 5 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 70436-121-35 | Slate Run Pharmaceuticals | 20 February 2025 |
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 16 November 1992 | 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 Gadoteridol 5586 mg/20 mL injection.
Other strengths and forms of Gadoteridol
Clinical summary
Gadoteridol is a paramagnetic contrast agent indicated for magnetic resonance imaging (MRI) to visualize, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Gadoteridol 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 GadoteridolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ProHance prescribing information (Bracco Diagnostics) · U.S. National Library of Medicine, DailyMed
Need Gadoteridol 5586 mg/20 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.