Medicine
Axumin 221 mCi/mL injection
Axumin 221 mCi/mL injection is a prescription medicine containing Fluciclovine f-18 for intravenous use, marketed by Blue Earth 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 Axumin at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Fluciclovine f-18
- Brand
- Axumin
- Strength
- 221 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 30 mL, 50 mL
- Marketing authorisation holder
- Blue Earth Diagnostics
- Manufacturer
- Blue Earth Diagnostics
- Origin register
- US FDA, United States
- Storage
- Store Axumin at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Store Axumin within the original container in radiation shielding.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V09IX12 Fluciclovine f-18
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 May 2016
- Identifiers
- DailyMed set ID 389a502e-a7d5-43dd-b6bf-f022ff23f3b9NDC 69932-001Application NDA208054
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 |
|---|---|---|---|
| 30 mL in 1 vial, multi-dose | 69932-001-30 | Blue Earth Diagnostics | 27 May 2016 |
| 50 mL in 1 vial, multi-dose | 69932-001-50 | Blue Earth Diagnostics | 27 May 2016 |
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 27 May 2016 | 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
Clinical summary
Fluciclovine f-18 is a radioactive diagnostic agent indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. MedsAcross supplies Fluciclovine f-18 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 Fluciclovine f-18For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Axumin prescribing information (Blue Earth Diagnostics) · U.S. National Library of Medicine, DailyMed
Need Axumin 221 mCi/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.