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MedsAcross

Medicine

Netspot kit

68ga-dotatate · Intravenous · Advanced Accelerator Applications
Available on requestPrescription onlyUS FDA

Netspot kit is a prescription medicine containing 68ga-dotatate 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

For prolonged storage, store NETSPOT in its original packaging at room…

Key facts

Active ingredient (INN)
68ga-dotatate
Brand
Netspot
Dosage form
Kit
Route
Intravenous
Packs
1 kit
Marketing authorisation holder
Advanced Accelerator Applications
Manufacturer
Advanced Accelerator Applications
Origin register
US FDA, United States
Storage
For prolonged storage, store NETSPOT in its original packaging at room temperature below 25°C (77°F) (do not freeze). After radiolabeling with activities of up to 1,110 MBq (30 mCi), keep gallium Ga 68 dotatate injection upright with an appropriate shielding to protect from radiation, at a temperature below 25°C (77°F) (do not freeze), and use within 4 hours.
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
1 June 2016
Identifiers
DailyMed set ID b2b3be70-17d8-4093-896c-f1c54a2cf242NDC 69488-001Application NDA208547

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

PackCodeLabelerMarketed since
1 kit in 1 kit * 1 injection, powder, lyophilized, for solution in 1 vial, single-dose69488-001-40Advanced Accelerator Applications1 June 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

68ga-dotatate is a prescription medicine indicated with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. It is available as kits for intravenous use. MedsAcross supplies 68ga-dotatate 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 68ga-dotatate

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Netspot kit 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.