Home NDC 40098-101 Fludeoxyglucose F-18
Product NDC 40098-101
11-digit product format 400980101
Labeler code 40098
Product ID 40098-101_2b497301-b276-f7b2-e063-6294a90aa5d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludeoxyglucose F-18
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Trustees of the University of Pennsylvania
Application ANDA203801
Marketing category ANDA
Marketing start 2014-10-30
Substance FLUDEOXYGLUCOSE F-18
Active strength 200 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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 40098-101 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 40098-101 40098-101-19 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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 A203801-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203801-001 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 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203801-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP 2014-10-29 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-18 200 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 40098-101-19 Fludeoxyglucose F-18 25 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 25 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40098-101 FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA] 15 Current NDC, Legacy NDC, 1 package rows 20250112_84f1aeab-685d-47fd-a8e9-e724979c4ce6.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 40098-101-19 40098010119 25 mL in 1 VIAL, MULTI-DOSE (40098-101-19) 25 ml 2014-10-30 0000-00-00 No No Current