Fludeoxyglucose

Manufacturer
Houston Cyclotron Partners LP dba Cyclotope
Effective date
2018-12-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:34:45

Label at a glance#

ProductFludeoxyglucose F18
Active ingredientFLUDEOXYGLUCOSE F-18
Label structure6 sections

Label contents#

Full prescribing information#

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Multiple-dose glass vial containing 0.74-18.5 GBq/mL (20-500 mCi/mL) of Fludeoxyglucose F 18 Injection and 4.5 mg of sodium chloride in citrate buffer (approximately 16 - 17 mL volume) for intravenous administration.

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available.

11 DESCRIPTION

DESCRIPTION SECTION

11.1 Chemical Characteristics

SPL UNCLASSIFIED SECTION

Fludeoxyglucose F 18 Injection 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-[ 18F]fluoro-D-glucose has the molecular formula of C 6H 11 18FO 5with a molecular weight of 181.26, and has the following chemical structure:

Image of chemical structureImage of chemical structure

Fludeoxyglucose F 18 Injection is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 18.5 GBq (20.0-500 mCi) of 2-deoxy-2-[ 18F]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.

11.2 Physical Characteristics

SPL UNCLASSIFIED SECTION

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 Emission Data for Fluoride F18
Radiation/Emission% per DisintegrationMean Energy
Positron (β+)96.73249.8 keV
Gamma (±) * 193.46511.0 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 5.7 R/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) mmCoefficient of Attenuation
00.00
40.50
80.25
130.10
260.01
390.001
520.0001

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 Fluoride F18
MinutesFraction Remaining
0 * 1.00
150.909
300.826
600.683
1100.500
2200.250

* Calibration time

16 HOW SUPPLIED / STORAGE AND DRUG HANDLING

HOW SUPPLIED SECTION

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 – 18.5 GBq/mL (20 - 500 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 16 - 17 mL. The contents of each vial are sterile, pyrogen-free and preservative-free.

NDC 47584-001-01

Store the Fludeoxyglucose F 18 Injection vial upright in a lead shielded container at 20º to 25°C (68º to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Distribute, store and dispose of Fludeoxyglucose F 18 Injection 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 F 18 Injection within 12 hours from the EOS time.

SPL UNCLASSIFIED SECTION

Manufactured and distributed by:

Cyclotope

Accelerated Medicine

8285 El Rio Suite 160

Houston, TX 77054

USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label for Container Closure System: 30 ml Vial

Vial labelVial label

Label for Lead Pig Container

Container labelContainer label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FLUDEOXYGLUCOSE F-18ACTIVE INGREDIENT0Z5B2CJX4D1
FLUDEOXYGLUCOSE F-18ACTIVE MOIETY0Z5B2CJX4D1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47584-00147584-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
FLUDEOXYGLUCOSE F-180Z5B2CJX4DACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203665-001FLUDEOXYGLUCOSE F18FLUDEOXYGLUCOSE F-1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-14c2088c7a36db…
2026-09-14 22:38:342026-08A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-1484e616aacf4f…
2026-08-18 06:07:402026-07A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUS2013-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203665-001FLUDEOXYGLUCOSE F1820-500mCi/MLINJECTABLE / INTRAVENOUSAPRS2013-02-143a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A203665-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203665-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203665-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203665-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203665-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203665-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203665-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203665-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A203665-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203665-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203665-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203665-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A203665-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203665-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203665-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203665-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203665-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203665-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203665-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203665-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203665-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203665-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203665-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203665-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203665-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203665-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203665-001AP1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a59fe15b-efc5-fcfe-e053-2995a90a60a0e3f039f5-efd3-423f-891e-90654951d03b2020-05-14Adverse reactionsExact identifier
spl set id: e3f039f5-efd3-423f-891e-90654951d03b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.