Home NDC 76326-001 Fludeoxyglucose
Product NDC 76326-001
11-digit product format 763260001
Labeler code 76326
Product ID 76326-001_412331b1-c993-e524-e063-6294a90a444b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludeoxyglucose F18
Dosage form INJECTION
Route INTRAVENOUS
Labeler The Regents of the University of Michigan
Application ANDA204531
Marketing category ANDA
Marketing start 2015-07-17
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 2026-12-31
Current FDA listing Yes 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-18 300 mCi/mL
Harmonized Identifiers# Field, Values table Field Values Unii 0Z5B2CJX4D
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76326-001-20 FludeoxyglucoseF18 19 mL in 1 VIAL, GLASS INJECTION 19 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76326-001 FLUDEOXYGLUCOSE F18 INJECTION [THE REGENTS OF THE UNIVERSITY OF MICHIGAN] 10 Current NDC, Legacy NDC, 1 package rows 20241027_35bfa064-4313-49e2-98d2-85a84d2c40a4.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76326-001-20 76326000120 19 mL in 1 VIAL, GLASS (76326-001-20) 19 ml 2015-07-17 0000-00-00 No No Current