Home NDC 67939-010 Fludeoxyglucose F 18
Product NDC 67939-010
11-digit product format 679390010
Labeler code 67939
Product ID 67939-010_d93db56f-430e-5490-e053-2995a90ace22
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludeoxyglucose F 18
Dosage form INJECTION
Route INTRAVENOUS
Labeler The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute
Application ANDA204498
Marketing category ANDA
Marketing start 2013-11-01
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204498-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204498-001 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 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204498-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-06-23 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fludeoxyglucose F 18
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUDEOXYGLUCOSE F-18 300 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67939-010-50 Fludeoxyglucose F 18 50 mL in 1 VIAL, MULTI-DOSE INJECTION 50 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67939-010 FLUDEOXYGLUCOSE F 18 INJECTION [THE UNIVERSITY OF UTAH DBA CYCLOTRON RADIOCHEMISTRY LAB / HUNTSMAN CANCER INSTITUTE] 16 Current NDC, Legacy NDC, 1 package rows 20220303_4439286d-2b7b-4403-9e4a-3b0aad10ad5b.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fludeoxyglucose F 18 FLUDEOXYGLUCOSE F 18 The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute 4439286d-2b7b-4403-9e4a-3b0aad10ad5b 2022-03-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 204498 application number: ANDA204498 ndc (product): 67939-010
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67939-010-50 67939001050 50 mL in 1 VIAL, MULTI-DOSE (67939-010-50) 50 ml 2020-05-20 0000-00-00 No No Current