Home NDC 76451-118-51 Fludeoxyglucose
Product NDC 76451-118
Requested package NDC 76451-118-51
11-digit product format 764510118
Labeler code 76451
Product ID 76451-118_47434382-85a5-899c-e063-6294a90ad8d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludeoxyglucose F18
Dosage form INJECTION
Route INTRAVENOUS
Labeler 3D Imaging Drug Design and Development LLC
Application ANDA203778
Marketing category ANDA
Marketing start 2012-01-02
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 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…
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 A203778-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203778-001 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 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203778-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-30 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
Brand name suffix F18
Listing expiration 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76451-118-10 FludeoxyglucoseF18 10 mL in 1 VIAL, GLASS INJECTION 10 3 76451-118-30 FludeoxyglucoseF18 30 mL in 1 VIAL, GLASS INJECTION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76451-118 FLUDEOXYGLUCOSE F18 INJECTION [3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC] 1 Current NDC, Legacy NDC, 2 package rows 20190215_2785ce60-86c9-42c2-ab0a-8c5d5adf60d3.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 76451-118-51 76451011851 10 mL in 1 SYRINGE, PLASTIC (76451-118-51) 10 ml 2018-12-17 0000-00-00 No No Current