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#
Contacts and useful links#
Label contents#
Full prescribing information#
3 DOSAGE FORMS AND STRENGTHS
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
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
11.1 Chemical Characteristics
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:
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
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).
| 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 5.7 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%.
| 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.
| Minutes | Fraction Remaining |
|---|---|
| 0 * | 1.00 |
| 15 | 0.909 |
| 30 | 0.826 |
| 60 | 0.683 |
| 110 | 0.500 |
| 220 | 0.250 |
* Calibration time
16 HOW SUPPLIED / STORAGE AND DRUG HANDLING
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
Label for Lead Pig Container
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| FLUDEOXYGLUCOSE F-18 | ACTIVE INGREDIENT | 0Z5B2CJX4D | 1 | |
| FLUDEOXYGLUCOSE F-18 | ACTIVE MOIETY | 0Z5B2CJX4D | 1 |
Products#
Every source-derived product name is available through these pages.
- Fludeoxyglucose F18
- FLUDEOXYGLUCOSE F-18
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 47584-001 | 47584-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FLUDEOXYGLUCOSE F-18 | 0Z5B2CJX4D | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203665-001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | 2013-02-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203665-001 | FLUDEOXYGLUCOSE F18 | 20-500mCi/ML | INJECTABLE / INTRAVENOUS | AP | RS | 2013-02-14 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A203665-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203665-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203665-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203665-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203665-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203665-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203665-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203665-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203665-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203665-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A203665-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A203665-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A203665-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A203665-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203665-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203665-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203665-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203665-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203665-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203665-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203665-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A203665-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A203665-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203665-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A203665-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A203665-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203665-001 | AP | 1 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a59fe15b-efc5-fcfe-e053-2995a90a60a0 | e3f039f5-efd3-423f-891e-90654951d03b | 2020-05-14 | Adverse reactions | e3f039f5-efd3-423f-891e-90654951d03b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


