Home NDC 81759-001 Fludeoxyglucose
Product NDC 81759-001
11-digit product format 817590001
Labeler code 81759
Product ID 81759-001_347c6beb-499f-af61-e063-6394a90a6011
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludeoxyglucose F-18
Dosage form INJECTION
Route INTRAVENOUS
Labeler BAMF Health Inc.
Application ANDA216125
Marketing category ANDA
Marketing start 2025-03-11
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216125-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP 2025-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216125-001 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.
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 A216125-001 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP 2025-03-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216125-001 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP 2025-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216125-001 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP 2025-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216125-001 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP 2025-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216125-001 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP 2025-03-11 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216125-001 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP 2025-03-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fludeoxyglucose
Brand name suffix F 18
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 81759-001-30 FludeoxyglucoseF 18 30 mL in 1 VIAL, GLASS INJECTION 30 1 81759-001-30 FludeoxyglucoseF 18 1 in 1 CONTAINER INJECTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81759-001 FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18) INJECTION [BAMF HEALTH INC.] 1 Current NDC, 2 package rows 20250514_347c6beb-499e-af61-e063-6394a90a6011.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 Sample Exclude flag Status 81759-001-30 81759000130 1 VIAL, GLASS in 1 CONTAINER (81759-001-30) / 30 mL in 1 VIAL, GLASS 2025-03-11 No No Current