Fludeoxyglucose F18 .3 Ci/mL Injection, Solution, 30 mL — NDC 69864-001-30 (Billing 69864-0001-30)
This is a package of 30 mL of Fludeoxyglucose F18 .3 Ci/mL Injection, Solution from The Methodist Hospital Research Institute, marketed since Apr 2012 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
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- FDA openFDA NDC Directory · synced Oct 1, 2026
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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 mL | 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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- CMS NADAC weekly file
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Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 69864-0001-30 You're viewing this Main listing | 30 mL in 1 VIAL, MULTI-DOSE | 2012-04-23 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fludeoxyglucose F18 .3 Ci/mLthis 69864-0001-30 | The | 30 ml | — | AP | FDA listed | — |
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- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
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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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- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
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Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1. Indications and Usage Fludeoxyglucose F18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures ( 1 ).
1.1Oncology For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2Cardiology For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
1.1Oncology For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2Cardiology For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
⏱️ Dosage and Administration ▾
2. Dosage and Administration Fludeoxyglucose F18 Injection USP emits radiation. Use procedures to minimize radiation exposure.
Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description( 11.2 )]. Fludeoxyglucose F18 Injection USP emits radiation.
Use procedures to minimize radiation exposure. Screen for blood glucose abnormalities. In the oncology and neurology settings, instruct patients to fast for 4 – 6 hours prior to the drug’s injection.
Consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to the drug’s administration ( 5.2 ). In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to the drug’s injection facilitates localization of cardiac ischemia ( 2.3 ). Aseptically withdraw Fludeoxyglucose F18 Injection USP from its container and administer by intravenous injection ( 2 ).
The recommended dose: for adults is 5 – 10 mCi (185 – 370 MBq), in all indicated clinical settings ( 2.1 ). for pediatric patients is 2.6 mCi (96.2 MBq) in the neurology setting ( 2.2 ). Initiate imaging within 40 minutes following drug injection; acquire static emission images 30 – 100 minutes from time of injection ( 2 ).
2.1Recommended Dose for Adults Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection.
2.2Recommended Dose for Pediatric Patients Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined [see Use in Special Populations( 8.4 )].
2.3Patient Preparation To minimize the radiation absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study. Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour.
Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [see Warnings and Precautions( 5.2 )]. Prior to Fludeoxyglucose F 18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 – 6 hours prior to the drug’s injection. In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to Fludeoxyglucose F18 Injection USP facilitates localization of cardiac ischemia.
2.4Radiation Dosimetry The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection are shown in Table 1. These estimates were calculated based on human 1 data and using the data published by the International Commission on Radiological Protection 2 for Fludeoxyglucose F 18. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups.
These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs. Table 1.
Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injection USP Organ Newborn (3.4kg) 1-year old (9.8kg) 5-year old (19kg) 10-year old (32kg) 15-year old (57kg) Adult (70kg) Bladder wall b 4.3 1.7 0.93 0.60 0.40
0.32Heart wall 2.4 1.2 0.70 0.44 0.29
0.22Pancreas 2.2 0.68 0.33 0.25 0.13 0.096 Spleen 2.2 0.84 0.46 0.29 0.19
0.14Lungs 0.96 0…
💊 Dosage Forms and Strengths ▾
3. Dosage Forms and Strengths Multiple-dose glass vial containing 0.74 - 11.1GBq (20 - 300 mCi/mL) of Fludeoxyglucose F18 Injection USP and 4.5 mg/mL sodium chloride in citrate buffer (approximately 25 - 30 mL volume) for intravenous administration. Multiple-dose glass vial containing 0.74 –
11.1GBq (20 – 300 mCi/mL) of Fludeoxyglucose F18 Injection USP and 4.5 mg/mL sodium chloride in citrate buffer (approximately 25 – 30 mL volume), for intravenous administration ( 3 ).
⛔ Contraindications ▾
4. Contraindications None None ( 4 )
⚠️ Warnings and Cautions ▾
5. Warnings and Precautions Radiation risks: use smallest dose necessary for imaging ( 5.1 ). Blood glucose abnormalities: may cause suboptimal imaging ( 5.2 ).
5.1Radiation Risks Radiation-emitting products, including Fludeoxyglucose F18 Injection USP, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker[see Dosage and Administration( 2.5 )].
5.2Blood Glucose Abnormalities In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F18 Injection USP administration.
5.1Radiation Risks Radiation-emitting products, including Fludeoxyglucose F18 Injection USP, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker[see Dosage and Administration( 2.5 )].
5.2Blood Glucose Abnormalities In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F18 Injection USP administration.
🤒 Adverse Reactions ▾
6. Adverse Reactions Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available.
Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact The Methodist Hospital Research Institute at 713- 441-3919 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7. Drug Interactions The interaction of Fludeoxyglucose F18 Injection USP with other drugs taken by patients undergoing PET imaging has not been studied.
👥 Use in Specific Populations ▾
8. Use in Specific Populations Lactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 9 hours after Fludeoxyglucose F 18 Injection ( 8.2 ). Pediatric Use: Safety and effectiveness in pediatric patients have not been established in the oncology and cardiology settings ( 8.4 ). See 17 for PATIENT COUNSELING INFORMATION.
8.1Pregnancy Risk Summary Data from published case series and case reports describe Fludeoxyglucose F 18 Injection USP crossing the placenta with uptake by the fetus (see Data). All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. However, published studies that describe Fludeoxyglucose F 18 Injection USP use in pregnant women have not identified a risk of drug-associated major birth defects, miscarriage, or adverse maternal or fetal outcomes.
If considering Fludeoxyglucose F 18 Injection USP administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Fludeoxyglucose F 18 Injection USP and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Human Data Data from published case series and case reports describe Fludeoxyglucose F 18 Injection USP crossing the placental barrier and visualization of radioactivity throughout the body of the fetus. The estimated fetal absorbed radiation dose from the maximum labeled dose (370 MBq) of Fludeoxyglucose F 18 was 10mGy with first trimester exposure to PET alone and 20mGy with first trimester exposure to PET/CT scan combination.
Long-term adverse radiation effects to a child exposed to Fludeoyxglucose F 18 Injection in utero are unknown. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50mGy, which represents less than 20mGy fetal doses.
8.2Lactation Risk Summary A published case report and case series show the presence of Fludeoxyglucose F 18 Injection USP in human milk following administration. There are no data on the effects of Fludeoxyglucose F 18 Injection USP on the breastfed infant or the effects on milk production. Exposure of Fludeoxyglucose F 18 Injection USP to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations).
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fludeoxyglucose F 18 Injection USP, any potential adverse effects on the breastfed child from Fludeoxyglucose F 18 Injection USPor from the underlying maternal condition. Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breastmilk and avoid close (breast) contact with the infant for at least 9 hours after the administration of Fludeoxyglucose F 18 Injection USP.
8.4Pediatric Use The safety and effectiveness of Fludeoxyglucose F18 Injection USP in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined.
In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F18 Injection USP have not been established in pediatric patients.
8.1Pregnancy Risk Summary Data from published case series and case reports describe Fludeoxyglucose F 18 Injection USP crossing the placenta with uptake by the fetus (see Data). All radiopharmaceuticals…
🧬 Clinical Pharmacology ▾
12 Clinical Pharmacology
12.1Mechanism of Action Fludeoxyglucose F 18 is a glucose analog that concentrates in cells that rely upon glucose as an energy source, or in cells whose dependence on glucose increases under pathophysiological conditions. Fludeoxyglucose F 18 is transported through the cell membrane by facilitative glucose transporter proteins and is phosphorylated within the cell to [18F] FDG-6-phosphate by the enzyme hexokinase. Once phosphorylated it cannot exit until it is dephosphorylated by glucose-6-phosphatase.
Therefore, within a given tissue or pathophysiological process, the retention and clearance of Fludeoxyglucose F 18 reflect a balance involving glucose transporter, hexokinase and glucose-6-phosphatase activities. Fludeoxyglucose F 18 is used to assess glucose metabolism. In comparison to background activity of the specific organ or tissue type, regions of decreased or absent uptake of Fludeoxyglucose F 18 reflect the decrease or absence of glucose metabolism.
Regions of increased uptake of Fludeoxyglucose F 18 reflect greater than normal rates of glucose metabolism.
12.2Pharmacodynamics Fludeoxyglucose F18 Injection USP is rapidly distributed to all organs of the body after intravenous administration. After background clearance of Fludeoxyglucose F18 Injection USP, optimal PET imaging is generally achieved between 30 to 40 minutes after administration. In cancer, the cells are generally characterized by enhanced glucose metabolism partially due to (1) an increase in activity of glucose transporters, (2) an increased rate of phosphorylation activity, (3) a reduction of phosphatase activity or, (4) a dynamic alteration in the balance among all these processes.
However, glucose metabolism of cancer as reflected by Fludeoxyglucose F 18 accumulation shows considerable variability. Depending on tumor type, stage, and location, Fludeoxyglucose F 18 accumulation may be increased, normal, or decreased. Also, inflammatory cells can have the same variability of uptake of Fludeoxyglucose F 18.
In the heart, under normal aerobic conditions, the myocardium meets the bulk of its energy requirements by oxidizing free fatty acids. Most of the exogenous glucose taken up by the myocyte is converted into glycogen. However, under ischemic conditions, the oxidation of free fatty acids decreases, exogenous glucose becomes the preferred myocardial substrate, glycolysis is stimulated, and glucose taken up by the myocyte is metabolized immediately instead of being converted into glycogen.
Under these conditions, phosphorylated Fludeoxyglucose F 18 accumulates in the myocyte and can be detected with PET imaging. In the brain, cells normally rely on aerobic metabolism. In epilepsy, the glucose metabolism varies.
Generally, during a seizure, glucose metabolism increases. Interictally, the seizure focus tends to be hypometabolic.
12.3Pharmacokinetics Distribution: In four healthy male volunteers, receiving an intravenous administration of 30 seconds in duration, the arterial blood level profile for Fludeoxyglucose F 18 decayed triexponentially. The effective half-life ranges of the three phases were 0.2-0.3 minutes, 10-13 minutes with a mean and standard deviation (STD) of 12 (±) 1 min, and 80-95 minutes with a mean and STD of 88 (±) 4 min. Plasma protein binding of Fludeoxyglucose F 18 has not been studied.
Metabolism: Fludeoxyglucose F 18 is transported into cells and phosphorylated to [18F]-FDG-6- phosphate at a rate proportional to the rate of glucose utilization within that tissue. [F 18]-FDG-6- phosphate presumably is metabolized to 2-deoxy-2-[F 18]fluoro-6-phospho-D-mannose([F 18]FDM-6- phosphate). Fludeoxyglucose F18 Injection USP may contain several impurities (e.g., 2-deoxy-2-chloro-D-glucose (ClDG)). Biodistribution and metabolism of ClDG are presumed to be similar to Fludeoxyglucose F 18 and would be expected to result in intracellular formation of 2-deoxy-2-chloro-6-phospho-D-glucose (ClDG-6-phosphate) and 2-deoxy-2…
📦 How Supplied / Storage and Handling ▾
16. How supplied/storage and handling Fludeoxyglucose F18 Injection USP is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 – 11.1GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D- glucose, at end of synthesis, in approximately 25 - 30 mL. The contents of each vial are sterile, pyrogen- free and preservative-free.
Store the Fludeoxyglucose F18 Injection USP vial upright in a lead shielded container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Store and dispose of Fludeoxyglucose F18 Injection USP in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State. The expiration date and time are provided on the container label.
Use Fludeoxyglucose F18 Injection USP within 12 hours from the EOS time.
📋 Description ▾
11. Description
11.2Physical Characteristics Fluorine F 18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV “annihilation” gamma photons, that are produced and emitted simultaneously in opposite direction when the positron interacts with an electron(Table 2). Table 2.
Principal Radiation Emission Data for Fluorine F 18 Radiation/Emission % Per Disintegration Mean Energy Positron(β+) 96.73 249.8 keV Gamma(±)* 193.46 511.0 keV *Produced by positron annihilation From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981) The specific gamma ray constant (point source air kerma coefficient) for fluorine 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 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3.
For example, the interposition of an 8 mm thickness of Pb, 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) shielding Shield thickness (Pb) mm Coefficient of attenuation 0 0.00 4 0.50 8 0.25 13 0.10 26 0.01 39 0.001 52 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.
Table 4. Physical Decay Chart for Fluorine F 18 Minutes Fraction Remaining 0* 1.000 15 0.909 30 0.826 60 0.683 110 0.500 220 0.250 *calibration time
11.1Chemical Characteristics Fludeoxyglucose F18 Injection USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[ 18 F]fluoro-D-glucose has the molecular formula of C H11 18FO5 with a molecular weight of 181.26, and has the following chemical structure: Fludeoxyglucose F18 Injection USP is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 11.1GBq (20.0-300 mCi) of 2-deoxy-2-[ F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer.
The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative. Chemical structure
11.2Physical Characteristics Fluorine F 18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV “annihilation” gamma photons, that are produced and emitted simultaneously in opposite direction when the positron interacts with an electron(Table 2). Table 2.
Principal Radiation Emission Data for Fluorine F 18 Radiation/Emission % Per Disintegration Mean Energy Positron(β+) 96.73 249.8 keV Gamma(±)* 193.46 511.0 keV *Produced by positron annihilation From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981) The specific gamma ray constant (point source air kerma coefficient) for fluorine 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 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3.
For example, the interposition of an 8 mm thickness of Pb, 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) shielding Shield thickness (Pb) mm Coefficient of attenuation 0 0.00 4 0.50 8 0.25 13 0.10 26 0.01 39 0.001 52 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.
Table 4. Physical Decay Chart for Fluorine F 18 Minutes Fraction Remaining 0* 1.000 15 0.909 30 0.826 60 0.683 110 0.500 220 0.250 *calibration time…
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| 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. |
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