Medicine
Choletec 45 mg powder for injection
Choletec 45 mg powder for injection is a prescription medicine containing Mebrofenin for intravenous use, marketed by Bracco Diagnostics, 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 the kit as supplied at 20-25°C (68-77°F) prior to and following…
Key facts
- Active ingredient (INN)
- Mebrofenin
- Brand
- Choletec
- Strength
- 45 mg
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials
- Marketing authorisation holder
- Bracco Diagnostics
- Manufacturer
- Bracco Diagnostics
- Origin register
- US FDA, United States
- Storage
- Store the kit as supplied at 20-25°C (68-77°F) prior to and following reconstitution.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 January 1987
- Identifiers
- DailyMed set ID fd085485-998d-42a3-879a-b2d96cb8aed7NDC 0270-0083Application NDA018963
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 |
|---|---|---|---|
| 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 0270-0083-20 | Bracco Diagnostics | 21 January 1987 |
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 |
| 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
Other strengths and forms of Mebrofenin
Clinical summary
Mebrofenin is a prescription medicine indicated as a hepatobiliary imaging agent. It is available as powder for injection for intravenous use. MedsAcross supplies Mebrofenin 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 MebrofeninFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Choletec prescribing information (Bracco Diagnostics) · U.S. National Library of Medicine, DailyMed
Need Choletec 45 mg powder for 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.