Medicine
Lutathera 10 mCi/mL injection
Lutathera 10 mCi/mL injection is a prescription medicine containing Lutetium oxodotreotide lu-177 for intravenous use, marketed by Advanced Accelerator Applications, 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 LUTATHERA. Store below 25°C (77°F). Store in the original…
Key facts
- Active ingredient (INN)
- Lutetium oxodotreotide lu-177
- Brand
- Lutathera
- Strength
- 10 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Advanced Accelerator Applications
- Manufacturer
- Advanced Accelerator Applications
- Origin register
- US FDA, United States
- Storage
- Do not freeze LUTATHERA. Store below 25°C (77°F). Store in the original package to protect from ionizing radiation (lead shielding).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V10XX04 Lutetium oxodotreotide lu-177
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 January 2018
- Identifiers
- RxCUI 1999682, 1999687DailyMed set ID 72d1a024-00b7-418a-b36e-b2cb48f2ab55NDC 69488-003Application NDA208700
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 |
|---|---|---|---|
| 1 vial in 1 package / 20.5 mL in 1 vial | 69488-003-01 | Advanced Accelerator Applications | 26 January 2018 |
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
Alternatives
Other makers and brands of Lutetium oxodotreotide lu-177 10 mCi/mL injection.
Clinical summary
Lutetium oxodotreotide lu-177 is a prescription medicine indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. It is available as injection for intravenous use. MedsAcross supplies Lutetium oxodotreotide lu-177 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 Lutetium oxodotreotide lu-177For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BEXLUTRY prescribing information (Curium) · U.S. National Library of Medicine, DailyMed
Need Lutathera 10 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.