Medicine
Gadobutrol 4535.4 mg/7.5 mL injection
Gadobutrol 4535.4 mg/7.5 mL injection is a generic prescription medicine for intravenous use, made by 4 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
Should freezing occur, gadobutrol injection should be brought to room…
Key facts
- Active ingredient (INN)
- Gadobutrol
- Brand
- Sold under the generic name
- Strength
- 4535.4 mg/7.5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 7.5 mL, 2 cartons of 7.5 mL, 20 vials of 7.5 mL and 2 more
- Manufacturers
- Zydus LifesciencesIndiaSlate Run PharmaceuticalsFresenius KabiViwit Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Should freezing occur, gadobutrol injection should be brought to room temperature before use. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). If allowed to stand at room temperature, gadobutrol injection should return to a clear and colorless to pale yellow solution.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V08CA09 Gadobutrol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 April 2023
- Identifiers
- DailyMed set ID 832e0ae1-4fe1-4dff-9978-c9200bcebb55, 007696d0-4b62-4937-9640-4ad619504df4, 4ea8ae43-22ca-40c0-be72-c91a321cafd1 +1NDC 70436-212, 65219-281, 70710-2064 +1Application ANDA217480, ANDA215061, ANDA219287
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, single-dose in 1 carton / 7.5 mL in 1 vial, single-dose | 70710-2064-6 | Zydus LifesciencesIndia | 14 July 2026 |
| 2 carton in 1 box / 10 vial, single-dose in 1 carton / 7.5 mL in 1 vial, single-dose | 65219-281-07 | Fresenius Kabi | 14 April 2023 |
| 20 vial, single-dose in 1 carton / 7.5 mL in 1 vial, single-dose | 70436-212-54 | Slate Run Pharmaceuticals | 20 October 2023 |
| 1 vial, single-dose in 1 carton / 7.5 mL in 1 vial, single-dose | 70436-212-80 | Slate Run Pharmaceuticals | 20 October 2023 |
| 10 vial, single-dose in 1 carton / 7.5 mL in 1 vial, single-dose | 42337-005-02 | Viwit Pharmaceutical | 11 June 2026 |
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 14 March 2011 | 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 Gadobutrol 4535.4 mg/7.5 mL injection.
Other strengths and forms of Gadobutrol
Clinical summary
Gadobutrol is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult, among other approved uses. MedsAcross supplies Gadobutrol 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 GadobutrolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gadavist prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Gadobutrol 4535.4 mg/7.5 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.