Fludeoxyglucose F18

Product NDC
24275-0185
11-digit product format
242750185
Labeler code
24275
Product ID
24275-0185_4395a8f3-f48b-e90c-e063-6294a90a7ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludeoxyglucose F18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
UCSF Radiopharmaceutical Facility
Application
ANDA203902
Marketing category
ANDA
Marketing start
2011-12-04
Substance
FLUDEOXYGLUCOSE F-18
Active strength
300 mCi/mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203902-001FLUDEOXYGLUCOSE F18FLUDEOXYGLUCOSE F-1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203902-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-093f01610625f2…
2019-09-15 20:21 UTC2019-09A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203902-001FLUDEOXYGLUCOSE F1820-300mCi/MLINJECTABLE / INTRAVENOUSAP2014-05-09e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203902-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203902-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203902-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203902-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203902-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203902-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203902-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203902-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203902-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203902-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203902-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203902-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203902-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203902-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203902-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203902-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203902-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203902-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203902-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203902-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203902-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203902-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A203902-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203902-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203902-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203902-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A203902-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203902-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203902-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203902-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203902-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203902-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203902-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203902-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203902-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203902-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203902-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203902-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203902-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203902-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Fludeoxyglucose F18
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUDEOXYGLUCOSE F-18300 mCi/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0Z5B2CJX4DInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
763958a2-6952-4c0d-8a4a-9c04acb62229Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a8297d3a-f6a8-4d2b-8fce-c063a35f1186Product name220251210
858c9b08-fb6b-48b9-8516-ea929654e228Product name220160606
6d7dfd10-cccc-49a1-a5c7-1842491e3644Product name220151125
b370ef4e-503e-4658-af90-e40f1dd3ff26Product name920151106
a838cd4c-e408-4023-a03d-912949043ddcProduct name220151029
bce34a5c-800a-42cd-a264-d5a0d09eed8aProduct name120150902
99a01b5c-59f4-409d-9148-0a2993e6f287Product name120150507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24275-0185-1Fludeoxyglucose F1817 mL in 1 VIAL, GLASSINJECTION1718

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDEOXYGLUCOSE F-18ACTIVE INGREDIENT0Z5B2CJX4DFLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F18) INJECTION [UCSF RADIOPHARMACEUTICAL FACILITY]9
FLUDEOXYGLUCOSE F-18ACTIVE MOIETY0Z5B2CJX4DFLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F18) INJECTION [UCSF RADIOPHARMACEUTICAL FACILITY]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24275-0185FLUDEOXYGLUCOSE F18 INJECTION [UCSF RADIOPHARMACEUTICAL FACILITY]17Current NDC, Legacy NDC, 1 package rows20241013_763958a2-6952-4c0d-8a4a-9c04acb62229.zip

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
Fludeoxyglucose F18FLUDEOXYGLUCOSE F18UCSF Radiopharmaceutical Facility763958a2-6952-4c0d-8a4a-9c04acb622292025-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203902
application number: ANDA203902
ndc (product): 24275-0185

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24275-0185-12427501850117 mL in 1 VIAL, GLASS (24275-0185-1) 17 ml2013-01-020000-00-00NoNoCurrent