Sodium Fluoride F18 200 mCi/mL Injection, 30 mL
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Fluoride F18 200 mCi/mLthis 65857-0300-30 | Cardinal | 30 ml | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65857-0300-30 You're viewing this | 30 mL in 1 VIAL, GLASS (65857-300-30) | 2015-07-30 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sodium Fluoride F-18 Injection, USP, is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F-18 Injection, USP, is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Sodium Fluoride F-18 Injection, USP, emits radiation and must be handled with appropriate safety measures ( 2.1 ). • Administer 300-450 MBq (8–12 mCi) as an intravenous injection in adults ( 2.4 ). • Administer approximately
2.1MBq/kg in children with a minimum of 19 MBq (0.5 mCi) and a maximum of 148 MBq (4 mCi) as an intravenous injection ( 2.5 ). • Imaging can begin 1–2 hours after administration; optimally at one hour post administration ( 2.7 ). • Encourage patients to void immediately prior to imaging the lumbar spine and bony pelvis ( 2.7 ).
2.1Radiation Safety - Drug Handling • Wear waterproof gloves and effective shielding when handling Sodium Fluoride F-18 Injection, USP. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. • Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. • Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F-18 Injection, USP. • The dose of Sodium Fluoride F-18 Injection, USP, should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed. • The final dose for the patient should be calculated using proper decay factors from the time of End of Synthesis (EOS), and measured by a suitable radioactivity calibration system before administration [ see Description ( 11.2 ) ].
2.2Radiation Safety - Patient Preparation • To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F-18 Injection, USP. • Encourage the patient to void one-half hour after administration of Sodium Fluoride F-18 Injection, USP, and as frequently thereafter as possible for the next 12 hours.
2.3Drug Preparation and Administration • Calculate the necessary volume to administer based on calibration time and dose. • Inspect Sodium Fluoride F-18 Injection, USP, visually for particulate matter and discoloration before administration, whenever solution and container permit. • Do not administer Sodium Fluoride F-18 Injection, USP, containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. • Aseptically withdraw Sodium Fluoride F-18 Injection, USP, from its container.
2.4Recommended Dose for Adults Administer 300–450 MBq (8–12 mCi) as an intravenous injection.
2.5Recommended Dose for Pediatric Patients In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi–4 mCi) were used.
2.6Radiation Dosimetry The age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F-18 Injection, USP, are shown in Table 1 . These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission [ 1 ] and the International Commission on Radiological Protection for Sodium Fluoride Injection [ 2 ]. The bone, bone marrow and urinary bladder are considered target and critical organs.
Table 1. Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F-18 Injection, USP Organ Estimated Radiation Dose mGy/MBq Adult 70 kg Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals , NUREG/CR-6345, page 10, 1996. 15 year 56.8 kg Data from ICRP publication 53, Radiation Dose to Pat…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Multiple-dose vial containing 370–7,400 MBq/mL (10–200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F-18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride F-18 Injection, USP, is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration. Multiple-dose vial containing 370–7,400 MBq/mL (10–200 mCi/mL) of no-carrier-added sodium fluoride F-18 at the end of synthesis (EOS) reference time in aqueous 0.9% sodium chloride solution ( 3 ).
Sodium Fluoride F-18 Injection, USP, is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Allergic Reactions: As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available ( 5.1 ). • Cancer Risk: Sodium Fluoride F-18 Injection, USP, may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker ( 5.2 ).
5.1Allergic Reactions As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available.
5.2Radiation Risks Sodium Fluoride F-18 Injection, USP, may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F-18 Injection, USP, have not been performed. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [ see Dosage and Administration ( 2.1 ) ].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS No adverse reactions have been reported for Sodium Fluoride F-18 Injection, USP, based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Sodium Fluoride F-18 Injection, USP, based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Cardinal Health at 1-800-618-2768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS The possibility of interactions of Sodium Fluoride F-18 Injection, USP, with other drugs taken by patients undergoing PET imaging has not been studied.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pregnancy: No human or animal data. Any radiopharmaceutical, including Sodium Fluoride F-18 Injection, USP, may cause fetal harm. Use only if clearly needed ( 8.1 ) • Nursing: A decision should be made whether to interrupt nursing after Sodium Fluoride F-18 Injection, USP, administration or not to administer Sodium Fluoride F-18 Injection, USP, taking into consideration the importance of the drug to the mother.
( 8.3 ) • Pediatrics: Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F-18 Injection, USP ( 8.4 ).
8.1Pregnancy Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F-18 Injection, USP, has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. Animal reproductive and developmental toxicity studies have not been conducted with Sodium Fluoride F-18 Injection, USP.
Prior to the administration of Sodium Fluoride F-18 Injection, USP, to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F-18 Injection, USP, should be given to a pregnant woman only if clearly needed.
8.3Nursing Mothers It is not known whether Sodium Fluoride F-18 Injection, USP, is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of Sodium Fluoride F-18 Injection, USP, or not to administer Sodium Fluoride F-18 Injection, USP, taking into account the importance of the drug to the mother. The body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours (10 half-lives).
To minimize the risks to a nursing infant, interrupt nursing for at least 24 hours.
8.4Pediatric Use In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi–4 mCi) were used. Sodium Fluoride F-18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F-18 Injection, USP.
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F-18 Injection, USP, has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. Animal reproductive and developmental toxicity studies have not been conducted with Sodium Fluoride F-18 Injection, USP.
Prior to the administration of Sodium Fluoride F-18 Injection, USP, to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F-18 Injection, USP, should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
8.4Pediatric Use In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi–4 mCi) were used. Sodium Fluoride F-18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F-18 Injection, USP.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Fluoride F-18 ion normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones.
12.2Pharmacodynamics Increased fluoride F-18 ion deposition in bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of bone.
12.3Pharmacokinetics After intravenous administration, fluoride F-18 ion is rapidly cleared from the plasma in a biexponential manner. The first phase has a half-life of 0.4 h, and the second phase has a half-life of 2.6 h. Essentially all the fluoride F-18 that is delivered to bone by the blood is retained in the bone.
One hour after administration of fluoride, F-18 only about 10% of the injected dose remains in the blood. Fluoride F-18 diffuses through capillaries into bone extracellular fluid space, where it becomes bound by chemisorption at the surface of bone crystals, preferentially at sites of newly mineralizing bone. Deposition of fluoride F-18 in bone appears to be primarily a function of blood flow to the bone and the efficiency of the bone in extracting the fluoride F-18.
Fluoride F-18 does not appear to be bound to serum proteins. In patients with normal renal function, 20% or more of the fluorine ion is cleared from the body in the urine within the first 2 hours after intravenous administration.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Fluoride F-18 ion normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sodium Fluoride F-18 Injection, USP, is supplied in a multiple-dose Type I glass vial with elastomeric stopper and aluminum crimp seal containing between 370 and 7,400 MBq/mL (10–200 mCi/mL) of no carrier-added sodium fluoride F-18, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume and total radioactivity per vial are variable. Each vial is enclosed in a shielded container of appropriate thickness.
The product is available in a 30 mL vial configuration with a variable fill volume. The NDC number is: NDC 65857-300-30 Storage Store at 25°C (77°F) in a shielded container; excursions permitted to 15–30°C (59–86°F). Use the solution within 12 hours of the EOS reference time.
Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.
📋 Description ▾
11 DESCRIPTION
11.1Chemical Characteristics Sodium Fluoride F-18 Injection, USP, is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F-18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F-18, has the molecular formula Na[ 18 F] with a molecular weight of 40.99, and has the following chemical structure: Na +18 F – Sodium Fluoride F-18 Injection, USP, is provided as a ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution.
Each mL of the solution contains between 370 MBq to 7,400 MBq (10 mCi to 200 mCi) sodium fluoride F-18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in 30 mL multiple-dose glass vials with variable total volume and total radioactivity in each vial.
11.2Physical Characteristics Fluoride F-18 decays by positron (β+) emission and has a half-life of 109.7 minutes. Ninety-seven percent of the decay results in emission of a positron with a maximum energy of 633 keV and 3% of the decay results in electron capture with subsequent emission of characteristic X-rays of oxygen. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron ( Table 2 ).
Fluorine F-18 atom decays to stable 18 O-oxygen. Table 2. Principal Emission Data for Fluoride F-18 Radiation/Emission % Per Disintegration Mean Energy Positron(β+) 96.73 249.8 keV Gamma(±) Produced by positron annihilation From: Kocher, D.C.
Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981 193.46 511.0 keV The specific gamma ray constant for fluoride F-18 is
5.7R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4.1 mm lead (Pb) or 2.9 mm tungsten (W) alloy. A range of values for the attenuation of radiation results from the interposition of various thickness of Pb or Tungsten alloy.
The range of attenuation coefficients for this radionuclide is shown in Table 3 . For example, the interposition of an 8.3 mm thickness of Pb or 5.8 mm thickness of W alloy with a coefficient of attenuation of 0.25 will decrease the external radiation by 75%. Table 3.
Radiation Attenuation of 511 keV Photons by lead (Pb) and Tungsten (W) alloy shielding Shield Thickness (Pb) mm Shield Thickness (W) Alloy mm Coefficient of Attenuation 0 0 0.00 4 3 0.50 8 6 0.25 13 9 0.10 26 19 0.01 39 28 0.001 53 37 0.0001 Table 4 lists the fraction of radioactivity remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide. Table 4.
Physical Decay Chart for Fluoride F-18 Time Since Calibration Fraction Remaining 0 calibration time 1.00 15 minutes 0.909 30 minutes 0.826 60 minutes 0.683 110 minutes 0.500 220 minutes 0.250 440 minutes 0.060 12 hours 0.011 24 hours 0.0001
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION
17.1Pre-Study Hydration Encourage patients to drink at least 500 mL of water prior to drug administration.
17.2Post-Study Voiding To help protect themselves and others in their environment, patients should take the following precautions for 12 hours after injection: whenever possible, use a toilet and flush several times after each use; wash hands thoroughly after each voiding or fecal elimination. If blood, urine or feces soil clothing, wash the clothing separately. Manufactured by: Cardinal Health 414, LLC 7000 Cardinal Place Dublin, OH 43017 Distributed by: Cardinal Health 414, LLC 7000 Cardinal Place Dublin, OH 43017