CardioGen-82
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82. CARDIOGEN-82 (rubidium Rb 82 generator)To produce rubidium Rb 82 chloride injection, for intravenous useInitial U.S. Approval: 1989
Approved
Approval ID
ee95aa18-9f2f-40eb-9b4c-583bea6f36bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 26, 2022
Manufacturers
FDA
Bracco Diagnostics Inc
DUNS: 849234661
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rubidium Chloride RB-82
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-0091
Application NumberNDA019414
Product Classification
M
Marketing Category
C73594
G
Generic Name
Rubidium Chloride RB-82
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 2, 2021
FDA Product Classification
INGREDIENTS (1)
RUBIDIUM CHLORIDE RB-82Active
Quantity: 150 mCi in 1 1
Code: F0Z746KRKQ
Classification: ACTIM