Home NDC 76326-001-20 Fludeoxyglucose
Product NDC 76326-001
Requested package NDC 76326-001-20
11-digit product format 763260001
Labeler code 76326
Product ID 76326-001_412331b1-c993-e524-e063-6294a90a444b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludeoxyglucose F18
Dosage form INJECTION
Route INTRAVENOUS
Labeler The Regents of the University of Michigan
Application ANDA204531
Marketing category ANDA
Marketing start 2015-07-17
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 1 .
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 A204531-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204531-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204531-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-07-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fludeoxyglucose
Brand name suffix F18
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 76326-001-20 FludeoxyglucoseF18 19 mL in 1 VIAL, GLASS INJECTION 19 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76326-001 FLUDEOXYGLUCOSE F18 INJECTION [THE REGENTS OF THE UNIVERSITY OF MICHIGAN] 10 Current NDC, Legacy NDC, 1 package rows 20241027_35bfa064-4313-49e2-98d2-85a84d2c40a4.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 Units Marketing start Marketing end Sample Exclude flag Status 76326-001-20 76326000120 19 mL in 1 VIAL, GLASS (76326-001-20) 19 ml 2015-07-17 0000-00-00 No No Current