Medicine
Gadoterate 5653.5 mg/15 mL injection
Gadoterate 5653.5 mg/15 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 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
- Sold under the generic name
- Strength
- 5653.5 mg/15 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 cartons of 15 mL, 10 vials of 15 mL
- Manufacturers
- Fresenius KabiSlate Run Pharmaceuticals
- 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, Gadoterate Meglumine Injection, USP should be brought to room temperature before use.
- 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 June 2022
- Identifiers
- DailyMed set ID 85404ca7-dbe7-4d06-b30c-4368dcd33b0b, e0655aac-9508-4141-94f5-fcca6af1c41dNDC 70436-123, 65219-084Application ANDA218073, ANDA215304
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 carton in 1 box / 1 vial in 1 carton / 15 mL in 1 vial | 65219-084-15 | Fresenius Kabi | 20 June 2022 |
| 10 vial in 1 carton / 15 mL in 1 vial | 70436-123-34 | Slate Run Pharmaceuticals | 28 June 2024 |
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 Gadoterate 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.