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Drax Exametazime 0.5 mg powder for injection

Technetium tc-99m exametazime · Intravenous · Jubilant Radiopharma
Available on requestPrescription onlyUS FDAIndian manufacturer

Drax Exametazime 0.5 mg powder for injection is a prescription medicine containing Technetium tc-99m exametazime for intravenous use, marketed by Jubilant Radiopharma, 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

Store Drax Exametazime kit at 15°C - 25°C (59°F - 77°F). Store and dispose of…

Key facts

Active ingredient (INN)
Technetium tc-99m exametazime
Brand
Drax Exametazime
Strength
0.5 mg
Dosage form
Powder for injection
Route
Intravenous
Packs
5 vials
Marketing authorisation holder
Jubilant Radiopharma
Manufacturer
Jubilant RadiopharmaIndia
Origin register
US FDA, United States
Storage
Store Drax Exametazime kit at 15°C - 25°C (59°F - 77°F). Store and dispose of technetium Tc 99m exametazime in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
V09AA01 Technetium tc-99m exametazime
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
17 August 2017
Identifiers
DailyMed set ID fa7811f9-2803-4126-8037-8f3e56462f9cNDC 65174-200Application NDA208870

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
5 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial65174-200-05Jubilant RadiopharmaIndia17 August 2017

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

Other strengths and forms of Technetium tc-99m exametazime

Clinical summary

Technetium tc-99m exametazime is a radioactive diagnostic agent indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. MedsAcross supplies Technetium tc-99m exametazime 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 Technetium tc-99m exametazime

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

Data sources

Need Drax Exametazime 0.5 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.