Home NDC 13267-234 Fludeoxyglucose
Product NDC 13267-234
11-digit product format 132670234
Labeler code 13267
Product ID 13267-234_6586ed67-0b87-4046-a7c1-274d39c10922
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludeoxyglucose F18
Dosage form INJECTION
Route INTRAVENOUS
Labeler THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
Application NDA021870
Marketing category NDA
Marketing start 2005-08-19
Substance FLUDEOXYGLUCOSE F-18
Active strength 400 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021870-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 N021870-002 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021870-002 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 3 · 84 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 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS RLD 2005-08-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS RLD 2005-08-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS RLD 2005-08-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 bb7c543d1eb4…
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUDEOXYGLUCOSE F-18 400 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 13267-234-45 FludeoxyglucoseF18 25 mL in 1 VIAL, GLASS INJECTION 25 20231214
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13267-234 FLUDEOXYGLUCOSE F18 INJECTION [THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH] 20231214 Current NDC, Legacy NDC, 1 package rows 20231215_dfd91498-4bfc-4d45-a9a3-cee6153ae573.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 13267-234-45 13267023445 25 mL in 1 VIAL, GLASS (13267-234-45) 25 ml 2005-08-19 0000-00-00 No No Current