RUBY-FILL
These highlights do not include all the information needed to use RUBY-FILL safely and effectively. See full prescribing information for RUBY-FILL.RUBY-FILL (rubidium Rb 82 generator)To produce rubidium Rb 82 chloride injection, for intravenous useInitial U.S. Approval: 1989
Approved
Approval ID
b3c0cc0c-2f4b-4e08-8a84-3cb77473c2e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2020
Manufacturers
FDA
Jubilant DraxImage Inc., dba Jubilant Radiopharma
DUNS: 243604761
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rubidium Rb 82
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65174-021
Application NumberNDA202153
Product Classification
M
Marketing Category
C73594
G
Generic Name
Rubidium Rb 82
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 29, 2019
FDA Product Classification
INGREDIENTS (1)
RUBIDIUM CHLORIDE RB-82Active
Quantity: 100 mCi in 1 1
Code: F0Z746KRKQ
Classification: ACTIM