Home NDC 52768-001 Fludeoxyglucose F-18
Product NDC 52768-001
11-digit product format 527680001
Labeler code 52768
Product ID 52768-001_34048aac-62bc-4f71-8592-5d685e2a0da5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUDEOXYGLUCOSE F-18
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Precision Nuclear, LLC
Application ANDA204546
Marketing category ANDA
Marketing start 2010-10-10
Substance FLUDEOXYGLUCOSE F-18
Active strength 500 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204546-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204546-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS 2015-04-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS 2015-04-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS 2015-04-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS 2015-04-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS 2015-04-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS 2015-04-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS 2015-04-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204546-001 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2015-04-07 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fludeoxyglucose F-18
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUDEOXYGLUCOSE F-18 500 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0Z5B2CJX4D Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 52768-001-30 2021-08-03 These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005 52768-001-30 2021-08-03 These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005 52768-001-50 2021-08-03 These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005 52768-001-50 2021-08-03 These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005 52768-001-30 2021-01-29 These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005 52768-001-30 2021-01-29 These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005 52768-001-50 2021-01-29 These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005 52768-001-50 2021-01-29 These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52768-001-30 Fludeoxyglucose F-18 1 in 1 CARTON INJECTION, SOLUTION 1 9 52768-001-30 Fludeoxyglucose F-18 30 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 30 9 52768-001-50 Fludeoxyglucose F-18 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 9 52768-001-50 Fludeoxyglucose F-18 1 in 1 CARTON INJECTION, SOLUTION 1 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52768-001 FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [PRECISION NUCLEAR, LLC] 8 Current NDC, Legacy NDC, 4 package rows 20240331_09ae2a6d-673a-423a-ba45-3c543061b103.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52768-001-30 52768000130 1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-30) / 30 mL in 1 VIAL, MULTI-DOSE 2010-10-10 0000-00-00 No No Current 52768-001-50 52768000150 1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-50) / 50 mL in 1 VIAL, MULTI-DOSE 2010-10-10 0000-00-00 No No Current