Home NDC 40028-511 Fludeoxyglucose F 18
Product NDC 40028-511
11-digit product format 400280511
Labeler code 40028
Product ID 40028-511_eae7ce3e-b6c1-4dee-81b2-d690ac938e35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludeoxyglucose F 18
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler PETNET Solutions, Inc.
Application ANDA079086
Marketing category ANDA
Marketing start 2008-07-29
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 2027-12-31
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 A079086-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079086-001 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 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079086-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS AP RS 2011-02-25 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 2027-12-31 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# NDC, Effective, Related label table NDC Effective Related label 40028-511-30 2021-04-20 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-30 2021-04-20 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-30 2021-04-20 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-50 2021-04-20 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-50 2021-04-20 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-50 2021-04-20 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-30 2021-01-29 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-30 2021-01-29 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-30 2021-01-29 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-50 2021-01-29 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-50 2021-01-29 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005 40028-511-50 2021-01-29 These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40028-511-50 Fludeoxyglucose F 18 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 24 40028-511-50 Fludeoxyglucose F 18 1 in 1 CAN INJECTION, SOLUTION 1 24 40028-511-99 Fludeoxyglucose F 18 1 in 1 CAN INJECTION, SOLUTION 1 24 40028-511-99 Fludeoxyglucose F 18 100 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 100 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUDEOXYGLUCOSE F-18 ACTIVE INGREDIENT 0Z5B2CJX4D FLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.] 11 FLUDEOXYGLUCOSE F-18 ACTIVE MOIETY 0Z5B2CJX4D FLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.] 11 ALCOHOL INACTIVE INGREDIENT 3K9958V90M FLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.] 11 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X FLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40028-511 FLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.] 20 Current NDC, Legacy NDC, 4 package rows 20241030_caaa9ab5-e3f4-489d-9f4c-0ecbee6fca83.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 40028-511-30 40028051130 1 VIAL, MULTI-DOSE in 1 CAN (40028-511-30) > 30 mL in 1 VIAL, MULTI-DOSE 2008-07-29 0000-00-00 No No Current 40028-511-50 40028051150 1 VIAL, MULTI-DOSE in 1 CAN (40028-511-50) / 50 mL in 1 VIAL, MULTI-DOSE 2008-07-29 0000-00-00 No No Current 40028-511-99 40028051199 1 VIAL, MULTI-DOSE in 1 CAN (40028-511-99) / 100 mL in 1 VIAL, MULTI-DOSE 2008-07-29 No No Current