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Medicine

Sodium fluoride f-18 200 mCi/mL injection

Sodium fluoride f-18 · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Sodium fluoride f-18 200 mCi/mL injection is a generic prescription medicine for intravenous use, made by 9 labelers, 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 at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).

Key facts

Active ingredient (INN)
Sodium fluoride f-18
Brand
Sold under the generic name
Strength
200 mCi/mL
Dosage form
Injection
Route
Intravenous
Packs
10 mL, 1 vial, 30 mL and 8 more
Manufacturers
PETNET SolutionsPrecision Nuclear3D Imaging Drug Design and DevelopmentBAMF HealthBiomedical Research Foundation of Northwest LouisianaCardinal HealthCyclotron Radiochemistry Lab / Huntsman Cancer InstituteKreitchman PET CenterSofie
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).
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 January 2011
Identifiers
DailyMed set ID eeaf4f42-e3c6-4e0a-aa79-89722511eaea, df1389d2-1b9b-4327-856e-5ba38118d389, 2bbd8f48-fdf9-45cb-8305-124a03f7a52c +6NDC 76451-018, 62072-500, 49609-102 +6Application ANDA203777, ANDA203936, ANDA203592 +6

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

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
10 mL in 1 vial, glass76451-018-103D Imaging Drug Design and Development2 January 2012
1 vial, glass in 1 container / 10 mL in 1 vial, glass81759-002-30BAMF Health6 December 2022
30 mL in 1 vial, multi-dose24562-002-30Biomedical Research Foundation of Northwest Louisiana22 January 2015
10 mL in 1 vial, multi-dose67939-020-10Cyclotron Radiochemistry Lab Huntsman Cancer Institute11 July 2012
30 mL in 1 vial, multi-dose62072-500-30Kreitchman PET Center23 May 2016
1 vial, multi-dose in 1 can / 30 mL in 1 vial, multi-dose40028-512-30PETNET Solutions26 January 2011
1 vial, multi-dose in 1 can / 50 mL in 1 vial, multi-dose40028-512-50PETNET Solutions26 January 2011
30 mL in 1 vial, multi-dose52768-125-30Precision Nuclear1 January 2011
50 mL in 1 vial, multi-dose52768-125-50Precision Nuclear1 January 2011
30 mL in 1 vial, multi-dose49609-102-01Sofie8 December 2011
30 mL in 1 vial, glass65857-300-30Cardinal Health30 July 2015

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
US FDAFirst approved 24 February 1972Drugs@FDA
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 Sodium fluoride f-18

Clinical summary

Sodium fluoride f-18 is a radioactive diagnostic agent indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. It is available as injection for intravenous use. MedsAcross supplies Sodium fluoride 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 Sodium fluoride f-18

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

Data sources

Need Sodium fluoride f-18 200 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.